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CONCURRENT VALIDATION
PROTOCOL
FOR
PURIFIED WATER SYSTEM
(Identification No. /DM/01)
AT
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM
Document No. /DM/01 Date of Issue Page No. 2 of 14
TITLE OF CONTENTS
1.0 Objective
2.0 Scope
3.0 Responsibility
Introduction
5.0
5.1 Locations
5.2 Frequency
Procedure
6.0
6.1 General aspects of validation program
6.2 Brief description of the Major components of the water
system
6.3 Schematic representation of Water system
Annexure - I
6.4 Schematic representation of Water system Indicating
Sampling points Annexure - II
6.5 Sampling locations, Test plan and frequency
1.0 OBJECTIVE:
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM
Document No. /DM/01 Date of Issue Page No. 3 of 14
1.1 This protocol describes the procedure for validating the entire water system to
ensure
the performance of the different sub-systems involved in the water treatment and
to assure the Quality of water.
2.0 SCOPE:
2.1 The Scope of this Protocol is applicable to the Water System of the Manufacturing
Facility of Pegasus Farmaco India Pvt.Ltd., 29, IDA, Bhongir, Nalgonda Dist.
3.0 RESPONSIBILITY
3.1 It is a joint responsibility of Engineering Department, Production Department,
Quality control and Quality Assurance Department. The detailed Responsibility
matrix is described in next page.
RESPONSIBILITY MATRIX
2 PROTOCOL REVIEW
MANAGER -QC
PROTOCOL APPROVAL
6
SUMMARY REPORT APPROVAL MANAGER-QA
5.0 INTRODUCTION
5.1 LOCATIONS
Sampling points are selected at predefined locations so as to monitor and assess
the effectiveness of each major system component. Chemical and
microbiological quality is tested as applicable and assessed. The detailed
locations of sampling points are schematically represented and specified in this
protocol.
5.2 FREQUENCY
The entire validation programme is sub-divided in to three phases.
5.2.1 Phase-I testing
5.2.1.1 A test period of 2 - 4 weeks is planned for monitoring the system
intensively. During this period the system should operate
continuously without failure or performance deviation. The test
plan details are provided at step 6.5.
5.2.2 Phase-II testing
5.2.2.1 A test period of 2 weeks is used for carrying out further
intensive monitoring after the satisfactory completion of phase 1.
Water can be used for manufacturing purposes during this
phase. The approach should demonstrate consistent operation
within established ranges.
5.2.3.1 Phase 3 runs for 1 year after the satisfactory completion of phase
2.The main objective of the study is to demonstrate
extended reliable performance. And ensure that seasonal
variations are evaluated. The sample locations, sampling
frequencies and tests are reduced to the normal routine pattern.
5.3 ACCEPTANCE CRITERIA
5.3.1 While framing acceptance criteria the design parameters of the major
components of the water systems is kept in mind. .. Acceptance criteria
for the Purified water has been established taking into consideration the
pharmacopeial limits for Purified water
6.0 PROCEDURE
The Validation Approach, Different Sampling and Testing Plan, Acceptance Criteria and
Validation Assessment are detailed under the following sub sections of this protocol
6.1 General aspects of validation program
6.2 Brief description of the major components of the water system
6.3 Schematic representation of DM unit indicating sampling points
6.4 Schematic representation of Recirculation loop system indicating sampling points
6.5 Sampling locations ,test plan and frequency
6.6 Test plan and acceptance criteria
6.7 Presentation of validation results
6.8 Evaluation of data and preparation of summary report
6.9 Conclusions and recommendations
6.10 Change control
6.1.1 The basic validation strategy is to maintain the system under normal
operating conditions during which frequent and extensive sampling and
testing is taken up in-order to assess the water system
6.1.2 Installation Qualification (IQ) protocol ensures all the requirements to
verify the installation of the components of the water system as per the
requirement. Operational qualification (OQ) protocol specifies and
ensures the functioning of different components as per the manufacturer
manual. During the validation consistency of the performance of the
system over several months of time is assessed.
6.1.3 Operating procedure and key control parameters
6.1.3.1 Validation programme includes the verification of the procedures
used to operate the system and to keep it in a state of control.
Examples of these procedures include start-up and flushing prior
to daily use, daily monitoring of key control parameters,
cleaning, s and sanitization of pipe lines and storage tanks etc.
These procedures shall be consistently followed during the
validation study so that adequate experimental data are
obtained to support their effectiveness. Personnel operating the
system shall be trained in these procedures. Other key
parameters and their operating ranges shall be finalized after the
validation programme.
6.1.4 Maintenance procedure
6.1.4.1 Maintenance procedures shall ensure consistent delivery of the
desired quantity and quality of water. These procedures may
include sanitization, filter sanitization and change, UV light
monitoring and replacement etc. All the preventive maintenance
procedures must be consistently followed.
6.1.5 During the Phase-I studies sampling programme include sampling of the
water for chemical and microbial testing at various points on DM water
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM
Document No. /DM/01 Date of Issue Page No. 7 of 14
Daily
RW/ 02 After Carbon Bed Microbial testing Daily
Daily
ROW /03 After Anion Bed Microbial analysis Daily
Daily
PW /01 After Mixed Bed Microbial analysis Daily
Chemical testing
PW 04 to
USER POINTS on pooled sample Daily Daily
PW 07
from user points
Daily
Chemical testing,
PW /05 Wash Room Daily
Microbial analysis
Daily
Chemical testing,
PW 06 Quality Control Daily
Microbial analysis
Daily
Chemical testing,
PW /07 Microbiology Daily
Microbial analysis
After the completion of monitoring the results covering all the three seasons, an
Annual Summary is made. Here the average value of each Quality parameter at
all sampling locations for each season is compared with respective limits.
Annual summary report is also correlated with the major break down (if any) and
normal preventive maintenance program of the Water System. Finally a
statement regarding the out come of the validation of the Water Treatment
System is made.
6.10 Change Control
In case of any subsequent changes to validated water treatment system like
change of a particular component etc can be made only through a proper change
control procedure. The procedure specifies a method for documenting proposed
changes and assigns responsibility to specific individuals for assessing the
impact of change on validated system.
An appropriate revalidation plan and a revalidation protocol will be required in
such case.
All change control, revalidations plan shall be reviewed and approved by Quality
Assurance
Engineering
Production
Quality control
Quality Assurance
VALIDATION PROTOCOL FOR PURIFIED WATER SYSTEM
Document No. /DM/01 Date of Issue Page No. 14 of 14