VMP E16 E01 V00

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Commissioning and Qualification Plan
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COMMISSIONING AND QUALIFICATION PLAN

FOR
GLAXOSMITHKLINE, BRASOV
QC AND ADMINISTRATION FACILITY
APPROVAL
Completion of the following signature block signifies the approver has read, understands, and agrees with the content of this
document.
Name
Job Title or Role
Signature
Date
(dd-mmm-yy)
Signs as having prepared this version of the Commissioning and Qualification Plan (CQP)
Authored by:
George Popa
Referee Technical
Documentation and
Validation
Authored by:
Lucian Groza
Validation Coordinator
Signs as agreeing with the content of CQP, with particular reference to scheduling of the work and documentation requirements,
agreeing to the application of project resources and material, as needed, to fulfil the objectives described, overall executive
responsibility.
Approved by:
Melania Comiati
QC-Analytical Manager
Approved by:
Maria Cosma
QC-Micro Manager
Approved by:
Levente Marton
Engineering Manager
Approved by:
Laurentiu Vegh
Project Manager
Signs as agreeing that the content of the CQP complies with Company Policies and local requirements, agreeing to the application of
QA/Validation resources, as needed, to fulfil the requirements described, authorising the document to be used as the source for the
commissioning and qualification activities described, agreeing system impact assessments rationales.
Approved by:
Sorin Marincat
Quality Manager
GlaxoSmithKline
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CONTENT
Section Title
Section
Abstract
Introduction and Scope
Project Description
Commissioning and Qualification Approach
Support Programmes
Management and Resources
Reference Documents
Version History
Family Tree
Appendix 1
System Impact Assessments
Appendix 2
FAT, Commissioning and Qualification Matrix
Appendix 3
Matrix of Required Standard Procedures
Appendix 4
Commissioning and Qualification Working Party
Appendix 5
Programme
Appendix 6
Documents
Appendix 7
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1.
ABSTRACT
GlaxoSmithKline will formally commission and, where appropriate, qualify facilities and
equipment which together form the project, QC AND ADMINISTRATION FACILITY, located
at Brasov, Romania. The facilities and equipment will be designed and constructed to meet
the regulatory requirements of Good Manufacturing Practice and in accordance with the
GlaxoSmithKline (GSK) Quality Management System.
2.
INTRODUCTION AND SCOPE

This document outlines the scope, approach, organisation and the scheduling of
commissioning and qualification activities for the project. This document has been written to
comply with the GSK Global Quality Policy and Global Quality Management Process.
This document:
Identifies appropriate policies and guidelines
Identifies the systems within the project scope
Defines the general approach to be used for the commissioning and qualification
activities
Establishes project management organisational structures, responsibilities and
programme
Defines "direct impact" or "indirect impact" (to be commissioned and qualified) and "no
impact" (to be commissioned only) parts of the project and documents the rationale
Details of specific commissioning and qualification rationales are contained in the C&Q
rationale. Specific test methods and acceptance criteria are contained in the individual
testing protocols.
The satisfactory completion of commissioning and qualification will be documented within the
Commissioning and Qualification Summary Report.
The scope of this document is limited to the commissioning and qualification of facilities and
process equipment. Other validation activities related to the moving of the existing
equipments from building 2 to building 16 will be covered as appropriate by other plans.
3.
PROJECT DESCRIPTION
An overview of the project scope is shown by the project family trees (Appendix I). The
following systems are included within this Commissioning and Qualification Plan:
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Area : Facilities & Utilities - 1431/9

Branch : Electrical - 1431/9/20
System Title : Sub Station and Generators - T010
Description : The Building 16 and associated Generator Package generally as
detailed below; the supply with electrical voltage it is made from main site
substation, for the back-up the building is designed with and Generator group for IT
infrastructure. Uninterrupted Power Supply (UPS) is considered for feeding power
supply to critical equipment agreed with site. Capacity of UPS worked out on the
basis of loads identified is as follows:
60 kVA for Lab Equipment.
10 kVA for auxiliary systems (i.e. BMS, Access Control, Fire Detection & Alarm
System, Intruder Control System, CCTV System and Emergency lights etc.).
For the present UPS system is not considered for the computers however,
provision for centralised UPS for the computers is made so that in future it can be
incorporated with minor modification.
Boundaries : As shown by drawing(s): E01.00 A
System Title : Low Voltage Electrical Power Distribution - T011
Description : LT power cables shall be 5 core, copper conductor, un-armoured with
inner extruded XLPE insulation and FRLS outer sheathings except for incoming
cables from MPCC Building No. 10 to PCC of Lab & Office building which will be
with round wire armouring and three and half core configuration. Complete power
distribution, switchgear selection, control and protection, earthling, cabling, cable
routing have been designed in the similar fashion with the existing system and will
become integral part of entire electrical system.
Boundaries : As shown by drawing(s): E01.00
System Title : Lighting - T012
Description : All lighting fixtures will be fed through proper lighting distribution
boards duly protected by over load and short circuit protections. Battery backed-up
exit light fixtures have been provided to mark the evacuation routes and above the
exit doors. The type of light fixtures has been selected based on room design basis,
layout, type of ceiling and area Ingress Protection (IP) classification. Energy efficient
Compact fluorescent lamp (CFL) and T-5 fluorescent lamp (FTL) have been
provided. Natural lighting combined with day light sensors has been considered to
save electricity during day time by utilizing maximum day light through windows in
the labs on the first floor & office area on the second floor (near the windows). The
locations of sensors and light fixtures are shown in the lighting layout drawings of
respective floors. Solar tube lights (ceiling type) will be provided for the middle
portion of the second floor office areas where natural light from windows is not
accessible. UV sterilizer lamps have been provided for Micro lab/ room nos. 101,
102, 107 and 108 to eliminate the problem of bad smell in these areas. Switches for
UV sterilizer lamps shall be located outside the respective rooms. Insect killer
devices will be mounted on the access zones in order to prevent the presence of
the insects inside the facility.
Boundaries : As shown by drawing(s): E05.00; E05.01; E05.02
System Title : Fire and Voice Alarms - T013
Description : Existing EPABX is having adequate capacity for new Lab & Office
building after discarding the use in building no. 2, 5 & 6. New multi pair telephone
cable will be laid from server room of Lab & Office building to building no. 10. Fire
Detection & Alarm systems shall be Addressable type comprising of smoke and
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heat detection units, manual call points, switching systems for disconnecting power
supply to AHUs in the event of detection. The Fire Alarm System conforms to EN54,
BS: 5839 / NFPA 71/72 in respect of design and installation. The system has a
microprocessor-based control and monitoring facility. The function of the system is
its ability to pinpoint location of fault (rise in temperature or detection of smoke) in
the form of Audio / Visual Alarm and Signal, while it exceeds the pre-set limit.
System Title : Access Control - T001
Description : Access control system is provided to prevent unauthorised entry into
the building and to minimise risk of theft. The Access control system is swipe card
based. Card readers shall be programmed to allow authorised entry according to
the level of access permitted to the card user. The locations of access control
systems are marked in the security system layout drawings. The entire system of
Lab & Office building will be hooked up to the existing Centralised PC based system
located in building no. 5. Existing Access control system for building nos. 2, 5, 6, 10
& 11 is connected through RS485 data communication cable to the centralised PC
based system located in building no.5. This will be relocated to the new gate house
adjacent to Lab & Office building. RS485 data communication cables from building
no. 10 and no. 11 shall be connected to relocated Centralised PC based system in
new gate house. Intruder Detection Sensors (Motion and Broken Glass Detectors)
are provided on each window at Ground Floor Level as marked on security system
layout drawings. Existing centralised control Intruder control Security System is
located in the building no.5 and connected to all other buildings through telephone
lines. Since EPABX is being relocated to Lab & Office building and multi pair
telephone cables are being rerouted between buildings accordingly no new
additional / extra cables are required to be laid for this system.
Boundaries : As shown by drawing(s): E04.30; E04.40
System Title : BEMS - T014
Description : The building is equipped with a BMS system which will monitor and
control all the utilities and installations within the building. The system is based on
DDC Technology distributed in the field. Main equipments and installations
controlled by the BMS are: HVAC, CWS, HWS, Compress Air, and Water Treatment
Plant. The system is composed from controllers which are connected in to a main
console PC Station. The PC Station is connected with the actual BMS system from
building 10. The BMS system can be operated via an HMI which allow the user to
modify the set-points, to generate energy consumption reports and program the
work time schedule.
Boundaries : As shown by drawing(s): BMS01; BMS03
System Title : EMS - E459
Description : In the existing arrangement temperature of equipments such as
fridges, incubators and ovens are measured by connecting external temperature
sensors in these equipments and monitoring these temperatures on 6-channel chart
recorders- temperature monitoring systems (TMS). Make and model of the TMS is
JUMO Logoprint 500 which is a 6-channel chart paper recorder for registering the
temperatures on the chart paper. High and low temperature limits may be set in
these chart recorders for providing an alarm output to LED annunciate. TMS and
alarm annunciate are installed in a wall mounted panel. The existing ovens, fridges
and incubators shall be shifted to the new building along with the existing
temperature sensors. In the proposed EMS configuration, the existing TMS, alarm
annunciate along with the wall mounted panels shall be relocated to the new
building. For measuring other environmental parameters of lab like temperature and
humidity two additional nos. of TMS, alarm annunciates and panel shall also be
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installed in the lab. For measuring the temperature and humidity of critical rooms,
sensors with local display shall be installed in the rooms. Sensors shall have inbuilt
transmitters giving standard 4-20 mA output. These transmitters shall be connected
to the TMS. High/ low temperature and humidity limits shall be set in these chart
recorders for providing alarm output to local LED annunciate installed in the labs. In
night times when the room temperatures and humidity are out of limit TMS shall
also give an alarm output to an annunciate which will be installed in New Gate
House. The First Part of the EMS system is design to monitor and record the areas
011, 113, 123, 124, 125,137 and for 5 fridge posted in the areas 124 &137; The
Second Part of the EMS system will monitor and record 22 temperature sensors
posted : 8 sensors on incubators from the room 101; 1 sensor on the incubator from
the room 102. Fridges; 1 sensor in the room 101; 3 sensors in the room 102 and 2
sensors in the room 108; Ovens: 3 sensors in the room 107
Boundaries : As shown by drawing(s):EMS 00.01 & EMS 00.02
System Title : CCTV and Security - T015
Description : Presently the site has CCTV system in existing buildings for Indoor
and Outdoor surveillance. The cameras are connected to a centralised Security
System in Control Room of Building no. 5. This centralised Security System shall be
shifted and relocated in New Gate House adjacent to Lab & Office building. All the
existing cameras are divided in two loops. One loop for Building No. 10 & 11 and
second loop for building 5 &6 and outdoor areas. CCTV system for Lab & Office has
been provided to monitor access into all critical service areas, critical laboratories,
entrance, exits, walkways and passage ways etc. CCTV system has been provided
in the outdoor areas and GF, FF & SF of the Lab & Office building in consultation
with site and the locations of CCTV cameras are marked on the security layout
drawings. This system shall consist of the following:
Pan / tilt / zoom network camera with suitable optical zoom facility & auto focus
lens.
Indoor type domed coloured camera
21 colour high resolution FTL monitor
DC power supply unit if required
RG-59 Co-axial armoured cable.
Clamps / saddles for conduit / cable clamping
All other fittings and accessories etc. including G.I. flexible conduit as required to
complete the system.
System Title : Voice and Data Cabling - I001
Description : Presently site is having centralised EPABX located in building no.5
server room and caters for voice requirements of buildings i.e. 2, 5, 6, 10, 11 & 14.
All buildings are connected to EPABX through multi pair telephone cables. Since
site is planning to shift this server room, this EPABX shall also be shifted along with
other components of server room to the new server room at second floor of Lab &
Office building Existing EPABX is having adequate capacity for new Lab & Office
building after discarding the use in building no. 2, 5 & 6. New multi pair telephone
cable shall be laid from server room of Lab & Office building to building no. 10.
Further distribution of voice network in building no.10, 11 & 14 shall remain same
Branch : Wet Pipework - 1431/9/21
System Title : Heating Hot Water System LTW01 - T016
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Description : 2 Nos. Boilers shall be factory packed unit complete with jacket, gas
and diesel manifold, burner and control mounted and wired. The hot water for
heating coil of AHUs, fan coils, radiators and duct coils will be ensured from branch
2 from hydraulic balancing vessel on heating plant. Steel pipes will be used for the
distribution circuits, with mineral wool insulated with fire protection covering
according FM GLOBAL. The thickness for the insulation is stated in the tender book
for execution, in accordance with the diameter of the pipe. The pipes which will be
mounted in external (terrace and external shaft) will have heat tracing under the
insulation. The distribution of each heating coil of AHU will have isolated valves,
control valves with 2way and motorised actuator, balancing valve and drainage
filters. The risers will be located into the shafts, with drainage and ventilation
facilities. The fan-coils for second floor will be equipped with 2 coils (heating and
cooling), control valves on both coils for the water temperature control, fan with 3
speeds, the necessary control to operate for all the design parameters. The
distribution for radiator will be in two separate main distributions: a distribution for
radiators which function in night time to assure the internal temperature when the
AHUs are shut-down; this distribution will be connected at branch 3 from hydraulic
balancing vessel - a distribution for radiators which function all time in technical
spaces, staircase and toilets. This distribution will be connected at branch 4 from
hydraulic balancing vessel. The radiators will be steel panel with 1 and 2 panels and
four points of connection. The radiators will be installed on the external and internal
walls will have thermostatic valves on supply pipe and hydraulic balancing valves on
return pipe Steel pipes will be used for the distribution circuits, with mineral wool
insulated. The thickness for the insulation is stated in the tender book for execution,
in accordance with the diameter of the pipe. The system is composing from Boilers;
Diesel tank located inside the boiler room shall be provided with pumps and piped
to the boiler. Diesel tank capacity shall be 1000 litres. Heat Exchanger for each
Boiler, Fuel Burning System for each Boiler, Blower for each Boiler, Gas Train for
each Boiler and distribution pumps.
Boundaries : As shown by drawing(s): BV/16/HV/24-IT/IC rev 02; BV/16/HV/37IT/IC rev 01; BV/16/HV/38-IT/IC rev 01; BV/16/HV-IT/IC - 34; BV/16/HV-IT/IC - 35;
BV/16/HV/22-IT/IC rev 02; BV/16/HV/07-IT/IC rev 02; BV/16/HV/07-IT/IC rev 02;
System Title : Chilled Water System CHW01 - T017
Description : The cold water thermal agent at temperature of 7C/12C will be
dedicated product within the cooling water plant placed on the terrace. The cold
water source is made of two compact aggregates with refrigerating cycle with Freon
R134a, having the condensers cooled with air and evaporators / heat exchangers
thermally insulated with mounted refrigerating powers. The cold water (mixture
glycol 45% + water) for cooling coil of AHUs, and fan coils will be ensured by
cooling water plant from terrace. Steel pipes will be used for the distribution circuits,
with rubber closed cell, fibber-free elastomeric foam type Armaflex, with fire
protection covering according FM GLOBAL. The thickness for the insulation is
stated in the tender book for execution, in accordance with the diameter of the pipe.
The pipes which will be mounted in external (terrace and external shaft) will have
protection with galvanized sheet material. The distribution of each cooling coil of
AHU will have isolated valves, control valves with 2 way and motorised
actuator, balancing valve and drainage filters. The risers will be located into the
shafts, with drainage and ventilation facilities.
Boundaries : As shown by drawing(s): BV / 16 / HV / 36 - IT/IC
System Title : Domestic Hot & Cold Water (DCW01 & DCH01) - T018
Description : Design of the water treatment plant shall be proven in practice and
shall be robust and reliable. The plant shall be suitable for continuous duty in an
outdoor location. All pressure vessels shall be designed to withstand maximum
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pressure equal to shut off pressure of the upstream pumps and shall be tested for
130% of this design pressure. All vessels / tanks shall be provided with necessary
manhole/ hand hole and cover. The supports for vessels/ piping, access ladder and
platform with handrails shall be provided for ease of operation and maintenance.
Any coupling, V-Belts, gear boxes and bearings installed shall have a service factor
of 1.5 over motor rated power. All moving parts shall have guards provided. For all
rotating equipment (pumps, blowers etc.) motor speed shall preferably be 1500 rpm.
For all rotating equipment noise level shall be maximum 80 dBA at 1 m distance
from the equipment. All structural/ cable rack within the battery limit shall be
provided by the vendor. Pipe/ cable racks shall run at a height of about 4 metres
from ground level. Battery limit flanges shall be as per ANSI B 16.5 standard, 150
lbs ratings. Minimum thickness of measuring tanks, dilution tanks and non-pressure
parts shall be 6 mm inclusive of 3 mm corrosion allowance. Materials used in the
entire plant shall be compatible with the service and pressure. Pressure gauges
shall be provided at discharge of each pump, blower and inlet/ outlet of each unit of
operation. Sample point shall be provided at inlet / outlet of each unit of operation.
Chemical tanks and storage tanks shall have level indicators (with isolation/ drain
valves) and overflow / drains. Each pump shall have suction isolation valve,
discharge non-return valve and isolation valve. Velocity in unlined pipes shall not
exceed 2.0 m/s.
Boundaries : As shown by drawing(s): BV / 16 / MC / 04 - RW
System Title : Purified Water - T019
Description : Purified Water Storage & Distribution System should be in
compliance with Current US Pharmacopoeia. The system should comprise of SS
316L tank internally electro polished to 0.5micron Ra with shadow free spray balls
(removable type), electrically traced 0.2 micron hydrophobic vent filter, sanitary
grade centrifugal pumps (1 working + 1 spare) with single VFD & UV unit with
intensity monitor. System shall be hot water sanitized at least 80 C at all parts of
the system with electric heaters in break tank. The procedure of sanitization shall be
fully automatic. The pressure in the distribution loop shall always be maintained
above minimum acceptable value i.e. 1.5 bar
Boundaries : As shown by drawing(s):
System Title : Sprinkler System - T020
Description : It is proposed to install a new FM global approved sprinkler system
along with all necessary equipment to provide protection to all the floors in the
facility. The fire protection is designed as per NFPA / FM global guide lines. The new
building is having a large no. of chemicals, reagents & solvents. However the
quantity of such chemicals shall be very small as they shall be used in the Labs for
testing only. Main hazardous material like solvents are being stored in existing
storage area and only small quantity shall be carried to Lab and shall be stored in
fire proof cabinets.
Boundaries : As Shown on Drawing(s) FS-01, FS-02; FS-03; FS-04; FS-05; FS-06;
FS-07
System Title : Drainage - wet (residual water) - T021
Description : The exterior domestic sewerage installation was rated according to
STAS 1795-87 the water debit in each section, taking into consideration the
maximum admitted filling degree, water speed and the normal assembly slope of
the pipe. The diameter and assembly slope for the sewerage pipes results from the
design and hydraulic conditions, the discharge speeds of waste waters must be
higher than the minimum self-cleaning speed and lower than the maximum admitted
speed in the pipes. The slopes and diameters of sewerage pipes will be read in the
column diagrams and in the plans of the sewerage installation.
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Boundaries : As Shown on Drawing(s): MC - 01-DW; MC - 02-DW; MC - 03-DW;

MC - 04-DW; MC - 05-DW
System Title : Potable Water - T022
Description : Raw Water Tank shall be provided of capacity 2.5 m3 and material of
construction as food grade HDPE. The tank shall be provided with overflow drain
and manhole. It shall be circular in construction and shall be installed at a raised
height for providing a positive suction head to the pumps. The inlet water supply line
to raw water tank shall be provided with strainer. The strainer shall be suitable for
online change over. The inlet line shall be provided with turbine type flow meter. The
storage tank shall be provided with 2Nos. of float valves.
The tank shall be
provided with Level switches which shall be interlocked with the solenoid valve
provided on the inlet supply line
Boundaries : As Shown on Drawing(s): MC - 01-RW; MC - 02-RW; MC - 03-RW;
MC - 04-RW
System Title : Technological Sewage - 1431/9/21/133
Description : The horizontal collecting pipes will be fabricated from grey cast iron
(type SML)according to (STAS 9392 73). The transition from cast iron
pipes to PVC pipes (outside the building) will be executed through the joint: PVC
connector cast iron.Upon the penetration through walls and fireproof boards,
fireproof sleeves will beprovided on the water and sewerage pipes and columns,
sleeves that would insure at least the same fire resistance limit with the one of that
particular construction element.The diameter and assembly slope for the sewerage
pipes results from the design and hydraulic conditions, the discharge speeds of
waste waters must be higher than the minimum self-cleaning speed and lower than
the maximum admitted speed in the pipes. The slopes and diameters of sewerage
pipes will be read in the column diagrams and in the plans of the sewerage
installation.Taking water from the floor will be made with sterile trap floor made from
stainlesssteel.Drains outside the buildings will made from PVC-KG SN4 pipeline
,code of color orange, sealed with elastomer gaskets, diameters and slopes should
be read in the assembly drawings.Buried pipes will be installed on a bed of sand,
with slopes of assembling provided in compliance with drawing parts.Sewerage
networks manholes will be made from plastic, specifically polyethylene,will be
provided with three inlets arranged at angles of 45 degrees and one exit.
Boundaries : As Shown on Drawing(s):MC - 01-ED, MC 01A-ED,MC - 02-ED,
MC - 03-ED, MC - 04-ED, MC - 05- ED
System Title : Solar Panels - 1431/9/21/135
Description : The Solar panels system consists of the vacuum tube collector
VIESSMANN VITOSOL 200 T for domestic hot water preparation,Bivalent domestic
hot water storage tank with two heat exhanger ( boiler/solar) total capacity 2000
litres and Vitosolic controler for solar domestic hot water preparation.
Boundaries : As Shown on Drawing(s): HV 24 IT/IC
System Title : Pluvial Drainage - 1431/9/21/136
Description : The collection system of storm waters will be performed in a separate
sewerage system. The design is executed with the observance of the regulations,
as well as the notifications provided by the regional utility supplier. Upon the
penetration through walls and fireproof boards, fireproof sleeves will be provided on
the water and sewerage pipes and columns, sleeves that would insure at least the
same fire resistance limit with the one of that particular construction element.
Rainwater sewer network will be composed of two types of rainwater sewer
networks, namely a rainwater sewer network that take rainwater from the roof of the
building through openings and pipes and released in the rainwater tank outside the
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building , and sewage network rainwater that takes rainwater from parking areas
and vehicle access through gutters. The surplus water collected from the roof of the
building will be drain in the open gutter near the tank. Rainwater taken from car
access and parking areas will pass through an oil separator type OLEOPATOR - K TN 50 that having a nominal flow of max. 50 l / s and then it will discharge on the
existing gutters. The rainwater sewer pipe network will be plastic, namely PVC-KG /
SN 2 or 4 orange colour code. Buried pipes will be installed on a bed of sand, with
slopes of installation provided in the compliance with drawing parts. Sewerage
networks manholes will be made from plastic, specifically polyethylene, will be
provided with three inlets arranged at angles of 45 degrees and one exit
Boundaries : As Shown on Drawing(s):MC - 01-RS, MC - 02 -RS, MC - 03-RS, MC
- 04-RS, MC - 05-RS
System Title : External hydrants - 1431/9/21/137
Description: The External hydrants system consists of the 4 external Hydrants FM
Global approved and HDPE pipe which will connect the existing Hydrant main ring
to cover the new building
Boundaries : As Shown on Drawing(s):FF - 01
Branch : Dry Pipework - 1431/9/22
System Title : Clean Gases - T023
Description: Gases shall be supplied from pressurised gas bottles located outside
the lab. Material of construction proposed for distribution piping / tubing will be
SS316. Nitrogen is not required by the lab, but has been included as it is required
for blanketing the waste solvent drums. The material of construction of the nitrogen
is carbon steel. Fuel gas will be used as fuel in the Hot Water Boilers. Site has an
existing supply connection in the plot where facility is being constructed. Natural gas
and Acetylene gas pipe supply line shall be provided with flame arrestors and
emergency cut-off devices in case of any fire. Centrally piped gasses will by used
for the following: Argon; Helium, Carbon dioxide, Acetylene & Nitrous Oxide Gas
each will have local filtration prior to point of use
Boundaries : As Shown on Drawing(s): MC -01G; MC -02G; MC -03G
System Title : Compressed Air - T024
Description: 2 No. Air Screw Compressor each of capacity 48 Nm3/hr with after
cooler and all other accessories will be designed as per manufacturers standard
practice. Free Oil Screw Air Compressor will be compact in design. The compressor
will be Air- Cooled. It will be provided with sound proof enclosure, drive motor,
suction filter-cum-silencer system, and after-cooler, moisture separator with trap for
after-cooler, controls and necessary connectors. Motor driver fan will be provided for
ventilation of sound proof enclosure. Compressor will be equipped with efficient
automatic loading/unloading system. The compressors shall start if the pressure
drops below 6.9 bar (g) and stop at 7.4 bar (g). The load / unload mechanism will be
with spring loaded un-loaders. Both compressors will be provided with VFD and
system will be designed to have a common control panel for the operation of the
compressors in parallel to meet the system air requirements. The compressor it will
have a system of cutting down the idling time and stopping the motor whenever
possible to result in energy efficient operations. The noise level has to be restricted
to 80 dBA under free field condition at a distance of 1m from source of the
equipment. In case an acoustic enclosure is necessary, all the instruments mounted
on it will be clearly visible and operable from outside. Pressure Relief Valve set
pressure shall be 110% of operating pressure. The compressor will have a userfriendly microprocessor based control panel to regulate, control and monitor
compressor operation. Bearing hat to be roller type on the drive side and
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combination of ball and cylindrical roller bearings on non-drive side and must be
sealed for life and designed for at least 30,000 hours of operation. The Compress
Air system will be equipped with filtration for removal of oil and moisture, air dryer
and all the measuring instrumentation.
Boundaries : As shown in the drawing(s): MC -01AC; MC -02AC; MC -03AC
System Title : Methane Gas - 1431/9/22/134
Description : According to the enclosed approbations and provisional notifications,
the installation will be built for the afore mentioned building in compliance with the
following: at the property limit, a regulation and measurement post will be placed (in
compliance with detail A), consisting of a RTG320 Dn50 regulator, a G65 volumetric
counter of maximum 100 mc/h and a FGN Dn50 filter; the entire equipment will be
placed in a special metal niche; starting from the regulation and measurement post,
a new 4installation will be executed for use above
ground along the existing parking place on supporting brackets attached to the
metal pillars of the surrounding fence, at a distance of maximum 4.8m; the
installation will thus be assembled on a distance of about 92,0m; then it will cross
the inner yard through the green area at the underground end of the parking lot;
the underground section will be made of PE100 SDR11 Dn110mm, at a depth of
90cm as compared to the ground level, in compliance with the details;
after emerging from the ground, near the fence on the western side of the building,
the new 4 OL installation will be again assembled above ground, on supporting
brackets attached to the metal pillars of the surrounding fence in line with the
building (approximately 30,0m); the new installation will cross the passage between
the property limit (the fence) and the building underground; the section will be made
of PE100 SDR11 Dn110mm in a Tv. OL Dn219mm protection pipe; the end towards
the building will emerge through a support wall which demarcates the passage from
the access area towards the building; after emerging from the ground (support wall),
the new installation 4 OL will cross the circulated area between the protection
wall and the building above ground (the distance between the support points is
2,2m); on the building outer wall, before the installation branches out towards
consumers, a seismic Kas de 4
valve will be assembled, as well as a by-pass with a stop valve; the new installation
will branch out as follows: a 4 sector towards the central heating systems on the
ground floor and a laboratory provided with 2 Bunsen bulbs on the 1st floor, above
the central heating room; a second sector will turn round about the western and
northern parts of the building in line with the laboratory situated on the 1st floor,
which will have another 6 Bunsen bulbs; the assembling of the new installations for
use both on the sides of the building and inside will be accomplished exteriorly, on
supporting brackets (for diameters greater than 2) and on pipe clamps/ bridges (for
smaller diameters) attached to the outer/ inner walls of the building; before the new
installations get inside, each branch will be provided with a fire valve and an
electrovalve directly powered by automatic gas detectors placed inside; the access
to this equipment is granted by a metal fixed staircase assembled in the proximity;
the central heating room will be endowed with air intake directly from the outside, on
an area of 0.2mp,which cannot be closed; burned gas from the central heating will
be removed by means of two 300 mm chimney made of insulated stainless steel,
18m high (up to the building attic); on the first floor, above the central heating room,
the two gas burners will be assembled in two niches provided with the possibility to
remove the burned gas (and the smell); in the other laboratories, another 6 gas
burners will be assembled independently, so that it is necessary to execute two
ventilation holes in the walls/ panes of the building with a view to removing burned
gas/ smells naturally;
all the rooms where methane gas consumers are placed will be provided with
automatic gas detectors with a response of minimum 2% methane in the air, which
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operate on the electrovalves assembled on the new installation outside the building;
Boundaries : As shown by drawing(s): G01.01 rev A, G01.02, G01.03, MG 01, MG
02
Branch : HVAC - 1431/9/23
System Title : HVAC16-01 - T025
Description: The Air Handling Unit No. 1 is designed to serve the rooms: Dining
Hall/ Servery, Food warming area, Store, Food Ent, Dish Wash. The AHU it is a
modulated, horizontal type (supply circuit along to extract circuit) for interior
mounting, FM Global approved double skin, with: Ventilation units 8064 m3/h,
cooling and heating elements, filtration elements and actuating elements. The AHU
is controlled via BMS.
Boundaries : As shown by system drawing(s): BV/16/HV/101
Description: The Air Handling Unit No. 2 is designed to serve rooms No 20 & 21
(Training Rooms). The AHU it is a modulated, horizontal type (supply circuit along to
extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation units 4500 m3/h, cooling and heating elements, filtration elements and
actuating elements. The AHU is controlled via BMS.
Description : The Air Handling Unit No. 3 is designed to serve rooms No 001/
001A/ 002/ 003/ 004/005/ 005A/ 006/ 007/ 009/ 010/ 016/ 013/ 014/ 017A. The AHU
it is a modulated, horizontal type (supply circuit along to extract circuit) for interior
mounting, FM Global approved double skin, with: Ventilation unit 7200 m3/h, cooling
and heating elements, filtration elements and actuating elements. The AHU is
controlled via BMS.
Description : The Air Handling Unit No. 4 is designed to serve rooms No 011. The
AHU it is a modulated, horizontal type (supply circuit along to extract circuit) for
interior mounting, FM Global approved double skin, with: Ventilation units 3690
m3/h, cooling and heating elements, filtration elements and actuating elements. The
AHU is controlled via BMS.
Description : The Air Handling Unit No. 5 is designed to serve rooms No 101/ 102/
103/ 107/ 108/ 109A/ 115. The AHU it is a modulated, horizontal type (supply circuit
along to extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation unit 8726 m3/h, cooling and heating elements, filtration elements and
106/ 109/ 110/ 111/ 112/ 113/ 114/ 116/ 117/ 118/ 119/ 120/ 121/ 122/ 126/ 127/ 128/
129/ 130/ 131/ 132/ 133. The AHU it is a modulated, horizontal type (supply circuit
along to extract circuit) for interior mounting, FM Global approved double skin, with:
Ventilation unit 11304 m3/h, cooling and heating elements, filtration elements and
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125/ 134/ 137/ 135/ 136/ 138/ 139/ 140. The AHU it is a modulated, horizontal type
(supply circuit along to extract circuit) for interior mounting, FM Global approved
double skin, with: Ventilation units 22284 m3/h, cooling and heating elements,
filtration elements and actuating elements. The AHU is controlled via BMS. The
system has on the exhaust of rooms 3 ventilators which are evacuating the air direct
outside of building.
203/ 204/ 205/ 206/ 207/208/ 209/ 210/ 211/ 211A/ 212/ 213/ 214/ 215/216/ 217/
218/219/220/223/224/225/226/227. The AHU it is a modulated, horizontal type
(supply circuit along to extract circuit) for interior mounting, FM Global approved
double skin, with: Ventilation unit 6689 m3/h, cooling and heating elements, filtration
elements and actuating elements. The AHU is controlled via BMS.
Branch : Building - 1431/9/24
System Title : Lift - T035
Description : The building will be provided with an hydraulic lift equipments The
equipment components shall be designed in such a way that there is an easy
access for all the components from the operation and maintenance point of view. All
types of compensators, supports, structures, etc., are provided. Each part of the
equipment is provided with lifting lugs to facilitate unloading, erection and
maintenance. All the exposed drives or driven equipment components will be
provided with suitable guards. Bidder will provide permanent non-rusting metal tags,
labels & necessary instructions.
Boundaries : This system it is a stand alone, the boundary of the system include
the electrical board of the lift but not the power breaker from the main distribution
board.
System Title : Building (general) - 1431/9/24/110
Description : The structure of the building consists of a system of metal beams and
poles with plates of reinforced concrete and single foundations. The partition walls
(check drawings) are self bearing and they do not have a structural role. The
external finishing of the facade consists of sandwich panels with basaltic wool. The
external windows have aluminium frame with insulated Low e double glazing.
Boundaries : Building Boundaries are extended to A00.01_SITE_PLAN
System Title : Analytical Area - 1431/9/24/124
Description : Designated area for the Analytical Lab is composed from 12
rooms:139(Wash)/ 138(Janitor)/ 136(ASH/ATOMIC)/ 135(Ignition)/ 134(HPLC)/
133(L. Toilets)/ 132(L. Lockers)/ 129(Office)/ 119(P A/L Lockers)/ 121(M A/L)/
140(Cons Glassware)/ 137(Analytical Lab), All the rooms are having finishes
depending on the process, Chemical Resistant PVC Flooring, Cardboard Partition
Walls, Box Ceiling.
Boundaries : The area is bounded until the utilities which are supplying the
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equipments and the area. As shown by system drawing(s):A04.02

System Title : Microbiological Lab Area - E16
Description : Designated area for the Microbiological Lab is composed from 14
rooms: 101(Incubator); 102(Clean Area); 103(A/L); 104(Office) 107(Media/Wash
Area);108(Micro ID);109(Corridor); 109A (A/L); 111(Lockers); 112(P/MAT, A/L);
113(Temp, Con, Store); 114(Store); 115(Waste Store); 116(Janitor); All the rooms
are having finishes depending on the process, Chemical Resistant PVC Flooring,
Cardboard Partition Walls, Box Ceiling.
Boundaries: The area is bounded until the utilities which are supplying the
equipments and the area As shown by system drawing(s):A04.01
System Title : Ground Floor - 1431/9/24/129
Description: The ground floor area is composed from 34 rooms:001 (Reception)/
001A Corridor / 002(Coffee Area)/003 WC Visitators/G01 Personnel Access/ G02
Control Security/ G03Locker Room/ G04 Toilets/ 004 (Meeting Room)/ 005 Luggage
Room/005A Corridor Access/ 006 Warehouse Furniture/ 007 Stair Case/ 009 Lift
Corridor/ 010 Corridor/ 011 Retained Samples/ 011A Lift Room/ 012 Technical Area/
012A Boiler Room/ 012B ACS Room/ 012C TGD Room/ 013 Archive/ 014 Wind
Fang/ 015 Stair Case/ 016 Locker Room/ 017 Handicapped Toilets/ 017A Cleaning
Office/ 017B Shaft/ 018 Ladies Toilets/ 019 Canteen/ 019A Catering Office/ 020
Training Room/ 021 Training Room/ 022 Stability Chamber. All the rooms are having
finishes depending on the destinations, Cardboard Partition Walls, Box Ceiling
Boundaries : As shown by architectural drawing(s): BV16AR0004
System Title : First Floor General Area - 1431/9/24/130
Description: The first floor general area is composed from 18 rooms: 105 Meeting
Room/ 106 PAL/ 108 Corridor/ 110 Locker/ Toilet/ 117 Packaging Lab/ 118 Staircase
Lobby/ 120 Corridor/ 122 Meeting Room/ 123 Liquid Solvents/ 124 AC Solid
Reagents/ 125 Sample Receiving/ 126 Storage Area/ 127 Loundry/ 128 Tea &
Coffee/128 Technical Area/ 130 Meeting Room/ 131 PAL/ 141 Staircase Lobby.
Boundaries: As shown by system drawing(s): BV16AR0006
System Title : Second Floor - 1431/9/24/131
Description: The area is used for open space offices, Server Room and Technical
Area and has 28 Rooms: 201 - Office/ 202 - Breakout Room/ 203 - Booth 1/ 204 Booth 2/205 - Booth 3/ 206 - Booth 4/ 207 - Meeting Room/ 208 - Office Serv Cen/
209 - Meeting Room/ 210 - Meeting Room/211 L T/ 211A - Loby Jan/ 212 - G.
Handicap. T/ 213 - Tea Coffee Area/ 214 Lockers/ Cloacks/ 215 Meeting Room TC/
216 - Meeting Room TC/ 217 - Meeting Room/ 218 - Lift Lobby/ 219 Meeting Room/
220 - Reg. Fil. Room/ 221 - Server & UPS/ 222 - Technical Area/ 223 - Corridor/ 224
- Office Serv Cen/ 225 - Office/ 226 - Staircase Lobby/ 227 - Staircase Lobby
Boundaries: As shown by system drawing(s): BV16AR0009
Area : Equipment - 1431/11
Branch : Safety Cabinets - 1431/11/25
System Title : Solvent Benches - T037-T040
Description: The system is design for drainage and collection of the disposed
chemicals from the Analytical Lab. The analytical area is provided with 4 working
stations equipped with venting system and drainage. The venting system of the
working stations is controlled via direct extraction fan, outside. The drainage is
composed from grey cast iron (type SML) The transition from cast iron pipes to
PVC pipes (outside the building) will be executed through the joint: PVC connector
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cast iron. The collection of all AFOS drainage will be made on outside of the
building on designated recipients for disposal. The AFOS units will have on the
working area utilities such purified water and soft water. The extracted air from the
process will be extracted with direct fans integrated in HVAC system and controlled
via VAV devices.
Boundaries: As shown by drawing(s): BV/16/HV/17-IT/IC
System Title : Fume Cupboards - T041-T048
Description : The analytical lab is provided in the processes with 8 cupboards
placed on the lab area. The cupboards are designed to prevent the formation of
dangerous potentially explosive atmospheres and protections from splashes of
hazardous substances in the internal work space. The cupboards will be integrated
in the HVAC system the evacuated air from the cabinets will be extracted with direct
fans controlled via VAV devices. The cupboards will be supplied with utilities such
soft water, compressed air. All the residuals produced in the process will by
evacuated on the general drainage system, system composed from outlet ducts antretur devices.
Boundaries : As shown by drawing(s):BV/16/HV/17-IT/IC
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4.
COMMISSIONING AND QUALIFICATION APPROACH

The purpose of the engineering commissioning and qualification activities within the scope of
this document is to demonstrate that the facility and process equipment reliably and
reproducibly perform to meet their intended functions. This forms the foundation for process
optimisation, development of process control loops and subsequent process validation. The
qualification program to be implemented will be consistent with Current Good Manufacturing
Practice (cGMP) regulations and guidelines. The following flowchart identifies the key
stages and outputs of the C&Q process.
Project Definition
System Impact Assessment
Commissioning & Qualification Plan
Direct and Indirect

Impact Systems
No Impact Systems
Enhanced Design Review
Design Review
Device Assessment
Commissioning & Qualification Rationale
Factory Acceptance Test Report/Protocol
Factory Acceptance Test Report/Protocol
Commissioning Report/Protocol
Commissioning Report/Protocol
Installation Qualification Report/Protocol
Operation Qualification Report/Protocol
Commissioning & Qualification Report
Figure 1. Key Commissioning and Qualification Stages
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The flow is applicable to facilities, process equipment and control systems with reference to
GSOP 1163 Control System Quality Management System (CSQMS). Embedded control
systems testing may form part of the equipment testing.
The following sub-sections describe the key stages of the commissioning and qualification
exercise.
4.1
System Impact Assessment

To determine the appropriate levels of documentation and testing required for each system
'system impact assessments' are carried out (Appendix 2). These documented assessments
categorise each defined system as 'direct impact', 'indirect impact' or 'no impact'.
Systems categorised as 'no impact' will be subject to a formal commissioning following good
engineering practice. Systems categorised as 'indirect impact' or 'direct impact' will be
subjected to commissioning and qualification.
4.2
Design Review and Enhanced Design Review

During the design phase of the project the design review process will be recorded by the
creation of Design Review (DR) Reports (for 'no impact' systems) and Enhanced Design
Review (EDR) Reports for 'direct impact' and 'indirect impact' systems. Each Design Review
Report will reference applicable design documentation and previously completed Design
Review Reports. EDR assessments will, in addition, address GMP requirements. Design
Review Reports will be subjected to approval by engineering with Enhanced Design Review
Reports additionally signed by QA/Validation.
The design review report will then form part of the overall project Design Qualification (DQ)
and will be referenced in the final DQ Report.
4.3
Device Assessments and Commissioning and Qualification Rationales

The scope and scale of a validation exercise must be based on good science and facts. An
important element of any commissioning and qualification exercise is therefore the
justification for the decisions taken. These decisions must be documented and approved,
providing the overall rationale for the testing to be performed; and equally for any testing that
is not to be performed, within system specific device assessments and qualification
rationales.
The device assessment will determine the criticality of each device within a direct impact
system and provide a supporting rationale for the assessment. Details of required process
operating limits and reference to test methodology will be recorded for critical instruments.
The commissioning and qualification rationale will determine the required commissioning and
qualification test criteria, based upon an assessment of the manufacturing process and the
device assessment. Testing within the qualification protocols will be directed towards the
components and attributes that have a direct impact on product quality. Details of the
specific test methods and acceptance criteria will be contained within the individual
commissioning and qualification protocols and subjected to approval before use.
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4.4
FAT, Commissioning and Qualification Reports/Protocols

Factory Acceptance Testing (FAT) and commissioning activities will be documented within
protocols, which will include appropriate test sheets. FAT and commissioning protocols will
be reviewed and pre-approved by engineering. The Installation Qualification (IQ) and
Operational Qualification (OQ) protocols will be reviewed and pre-approved by engineering
and Quality, fully define the objective, test procedure to be followed and the acceptance
criteria required for system certification. Protocols will be fully authorised in advance of the
activities taking place. Testing within the FAT, commissioning and qualification protocols will
be based upon the device assessments and the commissioning and qualification rationales.
The required FAT, commissioning and qualification protocols are identified in Appendix 3.
All commissioning and qualification protocols will have an associated report and deviation
summary, along with the recommended or agreed remedial action. The deviation summary
will also include a section for completion and sign-off when the required action has been
carried out.
4.5
Commissioning and Qualification Report

An overall commissioning and qualification summary report will be written, following the
review of individual commissioning and qualification reports/protocols. This report will
summarise the results, highlight and discuss any significant deviations from the
commissioning and qualification plan.
5.
SUPPORT PROGRAMMES
5.1
SOPs
SOPs will be required to cover the cleaning, operation and maintenance of systems. The
required procedures are identified in Appendix 4. However, it is anticipated that a unique
SOP will not be generated for each system. One SOP may be used to cover a number of
similar systems.
5.2
Training
All staff used for qualification operations will be trained in the appropriate SOPs before the
appropriate stage of qualification commences.
Staff operating or maintaining the equipment will receive appropriate training prior to the start
of cGMP production. Recording of training will be by the use of training record forms that will
reference the content of the training and be signed off by both the trainee and trainer.
5.3
Calibration
Calibration of critical instruments will be performed and recorded according to schedules
using approved SOPs. Critical device assessments will be carried out to determine which
devices require calibration, the accuracy required and the frequency of calibration required.
Planned maintenance procedures will ensure that critical instruments are recalibrated as
required.
Satisfactory completion of the system commissioning and/or qualification protocols will
confirm that the required critical calibrations have been carried out.
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5.4
Maintenance
Preventative maintenance programmes will be prepared for all major items of plant and
equipment. These programmes will be managed by the Engineering Department and will
comprise formal procedures, schedules, methods and records.
Satisfactory completion of system commissioning and/or qualification protocols will confirm
the presence of appropriate preventative maintenance programmes.
5.5
Change Control
Throughout the project life cycle any changes will be managed by project documentation.
A qualified system must not be changed unless a written and approved document authorises
the proposed change. At the end of operation qualification, changes will be managed by the
site change control.
5.6
'Live' Project Files

The purpose of this section is to define the 'project file' concept. During the life of the
qualification project, the Project Manager will collate documentation to produce Project Files.
The nominated document controller will be responsible for maintaining these documents
after handover. An index of all documents in each sub-section will be maintained to allow
rapid retrieval.
A file will be set up and maintained to encompass all those documents pertaining to a single
item of equipment or system which must be retained for commercial, qualification, GMP or
operational purposes. The file will comprise, as far as is practical, the original copies of all
documents. The files may be held complete in a central location, or sections of each one
may be held in different locations (ie qualification data with Quality, O&M manuals with
maintenance and order details with purchasing). In this case a register must be kept
centrally of where the file portions are held. A number of critical documents must be
maintained in an "as built" status during the life of the equipment. These should be
controlled into a single file and maintained to reflect changes made to the equipment.
6.
MANAGEMENT AND RESOURCES
6.1
Commissioning and Qualification Management

The execution of this plan will be undertaken by resource under the appointment and
direction of a Commissioning and Qualification Working Party, comprising representatives
from Engineering, Production, Technical and QA/Validation groups.
Details of the
Commissioning and Qualification Working Party are included within Appendix 5.
The Commissioning and Qualification Working Party will:
Arrange for commissioning and qualification plans, protocols and reports to be written by
suitably qualified persons.
Authorise commissioning and qualification plans, protocols and reports and all
associated amendments.
Ensure the activities identified within this plan are carried out to programme.
Ensure outstanding issues are addressed in a timely and controlled fashion.
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6.2
Review deviations from pre-approved protocols and decide an appropriate course of

action.
Outline Commissioning and Qualification Programme

Project activities are detailed in the programme contained within Appendix 6.
7.
REFERENCE DOCUMENTS
Reference to specific documents referred to or relied upon by this document are:
Ref.
Document No.
Document Title
GQP1204
The Validation Life-cycle
GQMP1008
The Validation Life-cycle
RBR/VMP/V15
Site Validation Master Plan for Europharm SA Brasov
8.
VERSION HISTORY
Date
(dd-mmm-yy)
29-Feb-12
Version
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Revised By
N/A
Reason for Revision

Initial Issue
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APPENDIX 1 FAMILY TREE

Area : Facilities & Utilities - 1431/9
Branch : Electrical - 1431/9/20
System Title : Sub Station and Generators - T010
System Title : Low VoltageElectrical Power Distribution - T011
System Title : Lighting - T012
System Title : Fire and Voice Alarms - T013
System Title : Access Control - T001
System Title : BEMS - T014
System Title : EMS - E459
System Title : CCTV and Security - T015
System Title : Voice and Data Cabling - I001
Branch : Wet Pipework - 1431/9/21
System Title : Heating Hot Water System LTW01 - T016
System Title : Chilled Water System CHW01 - T017
System Title : Domestic Hot & Cold Water (DCW01 & DCH01) - T018
System Title : Purified Water - T019
System Title : Sprinkler System - T020
System Title : Drainage - wet (residual water) - T021
System Title : Potable Water - T022
System Title : Technological Sewage - 1431/9/21/133
System Title : Solar Panels - 1431/9/21/135
System Title : Pluvial Drainage - 1431/9/21/136
System Title : External hydrants - 1431/9/21/137
Branch : Dry Pipework - 1431/9/22
System Title : Clean Gases - T023
System Title : Compressed Air - T024
System Title : Methane Gas - 1431/9/22/134
Branch : HVAC - 1431/9/23
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Branch : Building - 1431/9/24

System Title : Lift - T035
System Title : Building (general) - 1431/9/24/110
System Title : Analytical Area - 1431/9/24/124
System Title : Microbiological Lab Area - E16
System Title : Ground Floor - 1431/9/24/129
System Title : First Floor General Area - 1431/9/24/130
System Title : Second Floor - 1431/9/24/131
Area : Equipment - 1431/11
Branch : Safety Cabinets - 1431/11/25
System Title : Solvent Benches - T037-T040
System Title : Fume Cupboards - T041-T048
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APPENDIX 2 SYSTEM IMPACT ASSESSMENTS

Project Area: Facilities & Utilities
System No.
System Title
Assessment
Assessment Rationale
T010
Sub Station and

Generators
No Impact
The system forms part of a QC and Administration

facility which does not have an impact on the
quality of any pharmaceutical, biological, medical
device or GMP regulated healthcare product. The
system is therefore designated as no impact and
will be commissioned and documented to good
engineering practice with approval from
engineering.
T011
Low Voltage
Electrical Power
Distribution
No Impact

engineering.
T012
Lighting
No Impact

engineering.
T013
Fire and Voice

Alarms
No Impact

engineering.
T001
Access Control
Direct Impact
The system have an impact on the quality of

pharmaceutical product. The system is therefore
designated as direct impact and will be qualified.
T014
BEMS
No Impact

engineering.
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System No.
System Title
Assessment
E459
EMS
Direct Impact

facility. The system is used to record critical
parameters such as room temperatures and
equipment temperatures. The system is therefore
designated as direct impact and will be
commissioned and documented to good
engineering, with critical aspects qualified.
T015
CCTV and
Security
No Impact

engineering.
I001
Voice and Data

Cabling
No Impact
The system have no impact on the quality of

pharmaceutical product. The system is therefore
designated as no impact.
T016
Heating Hot
Water System
LTW01
No Impact

engineering.
T017
Chilled Water
System CHW01
No Impact

engineering.
T018
Domestic Hot &

Cold Water
(DCW01 &
DCH01)
No Impact

engineering.
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System No.
System Title
Assessment
T019
Purified Water
Direct Impact

facility. The water quality will need to be qualified to
meet the standards of European Pharmacopoeia /
United States Pharmacopoeia & WHO cGMP
guidelines Critical attribute are: Conductivity and
Viable bacteria, colony forming units. The system is
therefore designated as direct impact and will be
engineering practice with quality critical aspects
verified as part of the system qualification
T020
Sprinkler System
No Impact

engineering.
T021
Drainage - wet
(residual water)
No Impact

engineering.
T022
Potable Water
No Impact

engineering.
1431/9/21/13
3
Technological
Sewage
No Impact
The system is used to collect the effluents from the

labs; the system shall be connected through SML
pipes (indoor) and PVCKG (outdoor) to existing
network and conveyed to existing effluent treatment
plant (ETP)for treatment
1431/9/21/13
5
Solar Panels
No Impact
The system is used all year, but between the

months of May and August, the energy captured
from the solar collectors can assure all the
necessary power for domestic hot water. In the rest
of the months, the solar energy intake can
contributes to reduce the consumed fuel of heat
power plant
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System No.
System Title
Assessment
1431/9/21/13
6
Pluvial Drainage
No Impact
The takeover of storm waters from the building

platforms will be executed with antivegetation grill
storm receptors, through a sewerage system.The
water will be discharged in a rainwater collection
tank . Water will be used forspraying green areas
and parking lot.
1431/9/21/13
7
External
hydrants
Indirect Impact
The existing plant & QC building are protected by a

pressurised Hydrant system. It is proposed to
extend the existing Hydrant ring main to cover the
new building.The fire protection is designed as per
NFPA / FM global guide lines.
T023
Clean Gases
No Impact

engineering.
T024
Compressed Air
No Impact

engineering.
1431/9/22/13
4
Methane Gas
No Impact
The system will supply with Methane gas the 2

boilers and 8 bunsen bulbs
T025
HVAC16-01
No Impact

engineering.
T026
HVAC16-02
No Impact

engineering.
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 27 of 36
System No.
System Title
Assessment
T027
HVAC16-03
No Impact
The system is designated to serve rooms No 001/

001A/ 002/ 003/ 004/005/ 005A/ 006/ 007/ 009/
010/ 016/ 013/ 014/ 017A which does not have an
impact on the quality of any pharmaceutical,
biological, medical device or GMP regulated
healthcare product. The system is therefore
designated as no impact and will be commissioned
and documented to good engineering practice with
approval from engineering.
T028
HVAC16-04
Indirect Impact
The system is designed to serve rooms No 011

which can have an impact on the quality of
pharmaceutical, biological, medical device or GMP
regulated healthcare product. Parameters of those
areas are monitored by the EMS System. The
system is therefore designated as indirect impact
and will be commissioned and documented to good
verified as part of the system qualification.
T029
HVAC16-05
Indirect Impact
The system is designed to serve rooms No 101/

102/ 103/ 107/ 108/ 109A/ 115 which can have an
impact on the quality of pharmaceutical, biological,
medical device or GMP regulated healthcare
product. Parameters of those areas are monitored
by the EMS System. The system is therefore
designated as indirect impact and will be
T030
HVAC16-06
Indirect Impact

105/ 106/ 109/ 110/ 111/ 112/ 113/ 114/ 116/ 117/
118/ 119/ 120/ 121/ 122/ 126/ 127/ 128/ 129/ 130/
131/ 132/ 133 which does not have an impact on
the quality of any pharmaceutical, biological,
medical device or GMP regulated healthcare
product. The system is therefore designated as no
impact and will be commissioned and documented
to good engineering practice with approval from
engineering.
T031
HVAC16-07
Indirect Impact

124/ 125/ 134/ 137/ 135/ 136/ 138/ 139/ 140 which
can have an impact on the quality of
regulated healthcare product. Parameters of those
areas are monitored by the EMS System. The
system is therefore designated as indirect impact
and will be commissioned and documented to good
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 28 of 36
System No.
System Title
Assessment
T032
HVAC16-08
No Impact

202/ 203/ 204/ 205/ 206/ 207/208/ 209/ 210/ 211/
211A/ 212/ 213/ 214/ 215/216/ 217/
218/219/220/223/224/225/226/227 which does not
have an impact on the quality of any
regulated healthcare product. The system is
therefore designated as no impact and will be
engineering.
T035
Lift
No Impact

engineering.
1431/9/24/11
0
Building
(general)
No Impact

engineering.
1431/9/24/12
4
Analytical Area
Direct Impact
The area is designed to cover all the analytical

processes, the construction materials and finishes
of the area can impact on the quality of any
regulated healthcare product. The system is
therefore designated as direct impact and will be
E16
Microbiological
Lab Area
Direct Impact
The area is designed to cover all the

microbiological processes, the construction
materials and finishes of the area can impact on the
system is therefore designated as direct impact and
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 29 of 36
System No.
System Title
Assessment
1431/9/24/12
9
Ground Floor
No Impact

engineering.
1431/9/24/13
0
First Floor
General Area
No Impact

engineering.
1431/9/24/13
1
Second Floor
No Impact

engineering.
Project Area: Equipment

System No.
System Title
Assessment
T037-T040
Solvent
Benches
No Impact

facility which does not have an impact on the quality
of any pharmaceutical, biological, medical device or
GMP regulated healthcare product. The system is
engineering.
T041-T048
Fume
Cupboards
No Impact

facility which does not have an impact on the quality
of any pharmaceutical, biological, medical device or
GMP regulated healthcare product. The system is
engineering.
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 30 of 36
APPENDIX 3 FAT, DESIGN REVIEW, COMMISSIONING AND QUALIFICATION MATRIX

Project Area: Facilities & Utilities - 1431/9
System No.
System Title
DR
EDR
FAT
Com
IQ
OQ
T010
Sub Station and Generators
T011
Low Voltage Electrical Power Distribution
T012
Lighting
T013
Fire and Voice Alarms
T001
Access Control
T014
BEMS
E459
EMS
T015
CCTV and Security
I001
Voice and Data Cabling
T016
Heating Hot Water System LTW01
T017
Chilled Water System CHW01
T018
Domestic Hot & Cold Water (DCW01 &

DCH01)
T019
Purified Water
T020
Sprinkler System
T021
Drainage - wet (residual water)
T022
Potable Water
1431/9/21/13
3
Technological Sewage
1431/9/21/13
5
Solar Panels
1431/9/21/13
6
Pluvial Drainage
1431/9/21/13
7
External hydrants
T023
Clean Gases
T024
Compressed Air
1431/9/22/13
4
Methane Gas
T025
HVAC16-01
T026
HVAC16-02
T027
HVAC16-03
T028
HVAC16-04
T029
HVAC16-05
X
X
X
X
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 31 of 36
System No.
System Title
DR
EDR
FAT
Com
IQ
OQ
T030
HVAC16-06
T031
HVAC16-07
T032
HVAC16-08
T035
Lift
1431/9/24/11
0
Building (general)
1431/9/24/12
4
Analytical Area
E16
Microbiological Lab Area
1431/9/24/12
9
Ground Floor
1431/9/24/13
0
First Floor General Area
1431/9/24/13
1
Second Floor
IQ
OQ
Project Area: Equipment - 1431/11

System No.
System Title
DR
T037-T040
Solvent Benches
T041-T048
Fume Cupboards
EDR
FAT
Com
X
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 32 of 36
APPENDIX 4 MATRIX OF REQUIRED STANDARD PROCEDURES
Project Area: Facilities & Utilities - 1431/9

System No.
System Title
Operating
SOPs
Cleaning
SOPs
T010
Sub Station and Generators
T011
Low VoltageElectrical Power Distribution
T012
Lighting
T013
Fire and Voice Alarms
T001
Access Control
T014
BEMS
E459
EMS
T015
CCTV and Security
I001
Voice and Data Cabling
T016
Heating Hot Water System LTW01
T017
Chilled Water System CHW01
T018
Domestic Hot & Cold Water (DCW01 &

DCH01)
T019
Purified Water
T020
Sprinkler System
T021
Drainage - wet (residual water)
T022
Potable Water
1431/9/21/133
Technological Sewage
1431/9/21/135
Solar Panels
1431/9/21/136
Pluvial Drainage
1431/9/21/137
External hydrants
T023
Clean Gases
T024
Compressed Air
1431/9/22/134
Methane Gas
T025
HVAC16-01
T026
HVAC16-02
T027
HVAC16-03
T028
HVAC16-04
T029
HVAC16-05
T030
HVAC16-06
T031
HVAC16-07
Maintenance
SOPs
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 33 of 36
System No.
System Title
Operating
SOPs
Cleaning
SOPs
Maintenance
SOPs
T032
HVAC16-08
T035
Lift
1431/9/24/110
Building (general)
1431/9/24/124
Analytical Area
E16
Microbiological Lab Area
1431/9/24/129
Ground Floor
1431/9/24/130
First Floor General Area
1431/9/24/131
Second Floor
Project Area: Equipment - 1431/11

System No.
System Title
Operating
SOPs
Cleaning
SOPs
Maintenance
SOPs
T037-T040
Solvent Benches
T041-T048
Fume Cupboards
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 34 of 36
APPENDIX 5 COMMISSIONING AND QUALIFICATION WORKING PARTY

No.
1
Name and Function

Laurentiu Vegh
Project Manager
Sorin Marincat
Melania Comiati
Levente Marton
Csaba Kiss
George Popa
Claudia Pavel
Lucian Groza
OPTIM PM Team
Role
Ensure the activities identified within this plan are carried out to
programme.
Ensure outstanding issues are addressed in a timely and controlled
fashion.
Arrange for commissioning and qualification plans, protocols and
reports to be written by suitably qualified persons.
Approve commissioning and qualification plans, protocols and reports
and all associated amendments.
Approve deviations from pre-approved protocols and decide an
appropriate course of action.
Verify commissioning and qualification plans, protocols and reports
Review deviations from pre-approved protocols and decide an
Verify commissioning and qualification plans, protocols and reports
Review deviations from pre-approved protocols and decide an
Write commissioning and qualification protocols and reports.
Supervise third-parties commissioning and qualification activities.
Execute or supervise commissioning and qualification activities
Report imediately deviations from pre-approved protocols.
Write commissioning and qualification plans, protocols and reports.
Review commissioning and qualification protocols and reports issued
by team members (other than QA/Validation).
Review deviations from pre-approved protocols and suggest an
Write commissioning and qualification protocols and reports
Supervise third-parties commissioning and qualification activities
Report imediately deviations from pre-approved protocols
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 35 of 36
APPENDIX 6 PROGRAMME
ID
Tas k Nam e
Duration
LABORATORY & ADMINISTRATION BUILDING
Work
Start
Finis h
Apr
965 d
1,488 hrs
Sun 02-08-09
Thu 25-04-13
Project start
0d
0 hrs
Sun 02-08-09
Sun 02-08-09
Scope definition
162 d
0 hrs
Mon 03-08-09
Tue 16-03-10
Tue 01-05-12
Design
450 d
0 hrs
Fri 06-08-10
69
PIP approval
276 d
0 hrs
Fri 09-07-10
Fri 29-07-11
81
Permits
217 d
0 hrs
Mon 01-11-10
Tue 30-08-11
116
Procurem ent
580 d
0 hrs
Wed 19-05-10
Thu 09-08-12
243
Detailed engineering/Construction/Installation Work - Phase 1
181 d
1,488 hrs
Wed 31-08-11
Mon 14-05-12
470
Construction/Installation W ork - Phase 2
164 d
0 hrs
Wed 18-04-12
Mon 03-12-12
706
Com missioning & Validation
328 d
707
Com misionig and validation documentation preparation
711
Comm issioning Utilities Phase 1
0 hrs
Tue 04-10-11
Wed 16-01-13
80 d
0 hrs
Wed 02-05-12
Tue 21-08-12
162 d
0 hrs
Tue 04-10-11
Fri 18-05-12
Thu 19-04-12
712
Sewage s ystem
5d
0 hrs
Wed 11-04-12
713
Fire Fighting Sys tem
5d
0 hrs
Mon 05-03-12
714
Electrical
5d
0 hrs
Mon 23-04-12
Fri 27-04-12
715
Gas es dis tribution
5d
0 hrs
Tue 04-10-11
Mon 10-10-11
716
Earthing and ligthning
5d
0 hrs
Mon 14-05-12
Fri 18-05-12
717
Building and external architecture
10 d
0 hrs
Thu 05-01-12
Wed 18-01-12
718
Raw water
10 d
0 hrs
Thu 03-05-12
Wed 16-05-12
719
Rain w ater sewage s ys tem
10 d
0 hrs
Fri 11-11-11
Thu 24-11-11
720
Com misioning finis hed
0d
0 hrs
Fri 18-05-12
721
116 d
0 hrs
722
Hot Water sys tem
10 d
0 hrs
723
Chilled water sys tem
10 d
724
HVAC
15 d
725
BMS
10 d
726
Sewage s ystem
727
728
729
IT
730
Security
731
Electrical
732
Solvent waste
733
Gas es dis tribution
734
Solar heating
735
Fire alarm sys tem
736
737
738
Dies el generator
739
Earthing and ligthning
740
Building and external architecture
741
742
743
Comm issioning Utilities Phase 2
Tue 19-06-12
Fri 18-05-12
Tue 27-11-12
Mon 17-09-12
0 hrs
Thu 06-09-12
Wed 19-09-12
0 hrs
Wed 24-10-12
0 hrs
Wed 24-10-12
Tue 06-11-12
10 d
0 hrs
Tue 28-08-12
Mon 10-09-12
Fire Fighting Sys tem
10 d
0 hrs
Wed 22-08-12
Tue 04-09-12
Com press ed Air Sys tem
10 d
0 hrs
Thu 30-08-12
Wed 12-09-12
5d
0 hrs
Tue 18-09-12
Mon 24-09-12
15 d
0 hrs
Wed 07-11-12
Tue 27-11-12
5d
0 hrs
Tue 06-11-12
Mon 12-11-12
10 d
0 hrs
Wed 22-08-12
Tue 04-09-12
10 d
0 hrs
Wed 22-08-12
10 d
0 hrs
Tue 28-08-12
Mon 10-09-12
5d
0 hrs
Thu 08-11-12
Wed 14-11-12
Lift
5d
0 hrs
Mon 15-10-12
Fri 19-10-12
UPS
5d
0 hrs
Fri 24-08-12
Thu 30-08-12
3d
0 hrs
Fri 24-08-12
1d
0 hrs
Tue 06-11-12
Tue 06-11-12
10 d
0 hrs
Tue 18-09-12
Mon 01-10-12
Raw water
Com misioning finis hed
10 d
0 hrs
0d
0 hrs
55 d
0 hrs
Tue 19-06-12
Tue 27-11-12
Tue 23-10-12
Tue 13-11-12
Tue 04-09-12
Tue 28-08-12
Mon 02-07-12
Tue 27-11-12
Wed 16-01-13
744
Laboratory HVAC qualification
10 d
0 hrs
Tue 23-10-12
745
Stability cham bers
10 d
0 hrs
Wed 24-10-12
Tue 06-11-12
746
Acces control
10 d
0 hrs
Thu 08-11-12
Wed 21-11-12
747
EMS Validation
10 d
0 hrs
Mon 12-11-12
748
New Lab Equipm ent
15 d
0 hrs
Mon 12-11-12
Fri 30-11-12
749
Purified Water System
30 d
0 hrs
Tue 27-11-12
Wed 16-01-13
750
Qualification finis hed
0d
0 hrs
Wed 16-01-13
Wed 16-01-13
Wed 30-01-13
751
Mon 05-11-12
Fri 23-11-12
39 d
0 hrs
Wed 28-11-12
752
Com is ioning protocols clos ing and approval
5d
0 hrs
Wed 28-11-12
Tue 04-12-12
753
Qualification protocols clos ing and approval
5d
0 hrs
Thu 17-01-13
Wed 23-01-13
754
Validation report preparation and approval
5d
0 hrs
Thu 24-01-13
Wed 30-01-13
755
Com pletion
0 hrs
Wed 28-11-12
Tue 04-12-12
5d
0 hrs
Wed 05-12-12
Tue 11-12-12
757
Permit to use building
107 d
0 hrs
Tue 16-10-12
Fri 22-03-13
778
NDA APPROVAL
112 d
0 hrs
Mon 12-11-12
Thu 25-04-13
782
1.8 Shut Dow n of Old Buildings
52 d
0 hrs
Thu 07-02-13
0d
0 hrs
756
791
Com pletion & Handover

Dem obilis ation
End of the Project
5d
Thu 25-04-13
Aug
Sep Oct
Nov Dec Jan Feb Mar
Apr
2012
May Jun
Fri 09-03-12
Tue 04-09-12
Qualification
2011
May Jun Jul
Fri 19-04-13
Thu 25-04-13
18 May '12
GlaxoSmithKline
Document No.
Ver
Ver Date
Document Type
Page No
VMP/E16/E01/V00
V00
29-Feb-12
Page 36 of 36
APPENDIX 7 DOCUMENTS
The following documents must be issued in order to cover all validation activities related to this process:
Document Title
Plan de validare pentru instalatiile de climatizare si ventilatie pentru
blocul 16
Plan de validare pentru cladirea blocului 16
Document Number
VMP/T028/V00
VMP/E16/R01/V00
Plan de validare pentru instalatia de apa purificata din blocul 16
VMP/T019/V00
Plan de validare pentru sistemul de monitorizare si inregistrare

temperaturi si umiditati
VMP/E459/V00
Plan de validare pentru Sistem Control Acces
VMP/T001/V01
Under these documents will be developed specific validation documents (URS, design qualification reports,
qualification protocols and reports, traceability matrix etc)

VMP E16 E01 V00

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GlaxoSmithKline

Commissioning and Qualification Plan

COMMISSIONING AND QUALIFICATION PLAN

Job Title or Role

Commissioning and Qualification Plan

Introduction and Scope

Commissioning and Qualification Approach

Management and Resources

System Impact Assessments

FAT, Commissioning and Qualification Matrix

Matrix of Required Standard Procedures

Commissioning and Qualification Working Party

Commissioning and Qualification Plan

INTRODUCTION AND SCOPE

Commissioning and Qualification Plan

Area : Facilities & Utilities - 1431/9

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Boundaries : As Shown on Drawing(s): MC - 01-DW; MC - 02-DW; MC - 03-DW;

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Commissioning and Qualification Plan

Commissioning and Qualification Plan

actuating elements. The AHU is controlled via BMS.

Commissioning and Qualification Plan

equipments and the area. As shown by system drawing(s):A04.02

Commissioning and Qualification Plan

Commissioning and Qualification Plan

COMMISSIONING AND QUALIFICATION APPROACH

System Impact Assessment

Commissioning & Qualification Plan

Direct and Indirect

Enhanced Design Review

Commissioning & Qualification Rationale

Factory Acceptance Test Report/Protocol

Factory Acceptance Test Report/Protocol

Installation Qualification Report/Protocol

Operation Qualification Report/Protocol

Commissioning & Qualification Report

Figure 1. Key Commissioning and Qualification Stages

Commissioning and Qualification Plan

System Impact Assessment

Design Review and Enhanced Design Review

Device Assessments and Commissioning and Qualification Rationales

Commissioning and Qualification Plan

FAT, Commissioning and Qualification Reports/Protocols

Commissioning and Qualification Report

Commissioning and Qualification Plan

'Live' Project Files

MANAGEMENT AND RESOURCES

Commissioning and Qualification Management

Commissioning and Qualification Plan

Review deviations from pre-approved protocols and decide an appropriate course of

Outline Commissioning and Qualification Programme

The Validation Life-cycle

The Validation Life-cycle

Site Validation Master Plan for Europharm SA Brasov

Reason for Revision

Commissioning and Qualification Plan

APPENDIX 1 FAMILY TREE