Document No.

SMF/01/01

TITLE: Site Master File EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 1 of 35

SITE MASTER FILE

OF SOLITAIRE PHARMACIA PVT.LTD.
PLOT NO.25 Ext -1 HPSIDC AREA BADDI DISTT SOLAN HIMACHAL PRADESH-173205

Dosage Forms : Tablets (General & Hormonal )

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Document No. SMF/01/01 Sr.No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Title Cover Page Index General Detail Plant Location

TITLE: Index EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 2 of 35 Page No. 01 02 03 04&05 06&07 08&09 10 To 12 13 To 15 16 To 19 20 To 25 26 & 27 28 & 29 30 To 32 33 34 35

General Information Process Approach Personal Premises Ventilation system & Utilities Equipments Sanitation & Documentation Production Quality Control Distribution, Complaints and Product Recall Self Inspection Quality policy REVISION INDEX

Sr. No.

Date

Document No.

Change Details

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Document No. SMF/01/01

TITLE: General Detail EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 3 of 35

General Detail 3.1 3.2 3.3 Type of Industries Name of Dosage Forms Works (Factory) : Pharmaceuticals Industry. : General Tablet, Hormonal Tablet : Solitaire Pharmacia Pvt.Ltd Plot No. 25 Ext-1 HPSIDC Area, Baddi, Tehsil Nalagarh , Dist solan.(H.P) -173 205. Tel.: 09815777744 E-mail : radixbiotech@rediffmail.com : radixbiotech@yahoo.com

3.4

Marketing Office

: Solitaire Pharmacia Pvt.Ltd PLOT NO. 73,INDUSTRIAL AREA, PHASE II, CHANDIGARH. Tel.: 0172-5000477,5000478 Fax:5000477,2653293

3.5

Contact Persons

: Mr. Sanjeev Kumar Sethi (Managing Director)

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Document No. SMF/01/01

TITLE: Site Location Plan EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 4 of 35 A M A R A V A T

Annexure:4.1

Road No. 3

Plot no.19

SOLITAIRE PHARMACIA PVT. LTD. Plot no.25 Plot no26.

Plot no. Plot no.

Plot no. Plot no.18 Plot no 27 Plot no.28 Plot no.29 Road Road Spray Eng. Plot no. Plot no. Road

R O A D

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TITLE: Site Location Plan EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 5 of 35

DRAW SCATCH OF PLANT LOCATION FROM RAILWAY STATION Amaravati Appt. N.R.I Hospital KALKA RAILWAY STATION

Solitaire Pharmacia Pvt. Ltd.

NALAGARH

BADDI BUS STOP

BADDI

PINJOR

Annexure:4.2

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CHA NDIGARH

SHIMLA

Document No. SMF/01/01

TITLE: General Information EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 6 of 35

5.0 GENERAL INFORMATION

INTRODUCTION:
SOLITAIRE PHARMACIA PVT LTD., a Baddi (H.P.) based company established by Mr.Sanjeev Kumar Sethi, who has deep knowledge and vast experience of pharmaceutical business .He has now ventured in setting up state of the art pharma manufacturing facility of WHO,cGMP standards.

LOCATION :The plant is located at Baddi (Himachal Pradesh) in well connected industrial belt at a distance of 40 kms from Chandigarh on Pinjore Nalagarh Highway and is engaged in the manufacturing of solid dosage forms. The location is well connected with roads & railway station is about 20 kms at Kalka. The plant is located on 997 square meter plot. The factory is constructed and designed to meet the WHO, cGMP standards in consultation with highly qualified and experienced technical personnels approved by FDA for manufacturing and testing. The plant has AHU systems i.e., Air conditioning and Control humidity for all manufacturing departments to avoid cross contamination. Solitaire Pharmacia Pvt. Ltd has established a modern facility as per GMP standards to manufacture tablets (Non -Lactam) & Hormonal tablets . The unit is managed by experienced technical staff for production & quality control along with a team of expert technicians. The company has a pharmaceutical formulation plant located on the Ground floor for hormonal product & first floor for Non -Lactam respectively

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Document No. SMF/01/01

TITLE: General Information EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010 SALIENT FEATURES

PAGE No. 7 of 35

SOLITAIRE PHARMACIA PVT LTD. has observed and will practice the following:Factory designed and constructed as per GMP specification. Code of ethics in production and quality. Training to the personnel as per new guidelines. Electrification is done for easy energy audit. Illumination level 300 lux in all manufacturing areas. Water proofing of entire terrace slab. HPLC. UV-spectrophotometer under one roof.

Pre-Construction Anti-Termite Pest Control treatment for entire factory building The company has full fledged Quality Assurance, Purchase, Store, Production, Administration Engineering Dept., headed by very experienced personnels.
All standard operating procedure (work instruction) related with above production process are available with QA department & individual department. Facilities & list of equipment are available in site master file. List of Proposed products and other technical details are available in site master file. Plant is fully equipped with: 5.1 Exhaustive pest control system to ensure total freedom from insects and rodents. 5.2 Wall, floor and ceiling painted, free from crack, dust and dirt. 5.3 Full Fledged water system i.e.(a) Raw water system equipped with sand filter to ensure free from Insoluble and gaseous impurities (b) R.O water plant for Purified water Core team of HODs of Quality assurance/Quality Control, Engineering, Production & Adm. Working under Managing Director ensures effective quality system, planning and Implementation.

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Document No. SMF/01/01

TITLE: Process Approach EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 8 of 35

TYPE OF PRODUCTS LICENSED FOR MANUFACTURE WITH FLOWCHART MENTIONING PROCEDURE AND PROCESS FLOW : (i) Soltaire Pharmacia Pvt.Ltd manufactures wide range of pharmaceuticals formulations in General Categories of General Tablet & Hormonal tablets as per the approved Product List enclosed (ii) For process flow & procedure flow chart as per following.

Tablets
Weighting Sieving Mixing Wet or dry Granulation
Q.A-1

Drying

Visual Inspection

Q.A.-2

Compression

Lubrication

Sizing / Milling

Q.A. - 4

Coating
Q.A.-3

Tablet packing

Visual Inspection
Q.A.- 4

Final Release Sampling QA1 QA2 QA3 QA4 QA5 ------------Testing Water content, Bulk density Weight variation, Appearance, Colour Shape, D.T, Hardness, Friability D.T. Appearance D.T, Appearance, Pathogen and In process labeling, packing details

Tablet packing
Q.A.- 5

Final Release

Dispatch

Annexure:6.1

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TITLE: Process Approach EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 9 of 35

Solitaire Pharmacia Pvt.Ltd has facility to carry out Chemical Physico-chemical, Instrumental
Analysis

Solitaire Pharmacia Pvt.Ltd takes assistance from outside institution for testing its samples

Samples are sent for getting testing done where sophisticated instruments like IR, GC & BioAssay are required. .
PROCESS APPROACH: there will be basically four type of process in the organization a. Core process (customer related process) b. Management process (process carried out by top management /MR) c. Supporting process (process to help core /management process) d. Work process (process flow as per individual department wise Customer
Quality Policy & Quality Objective (Business Plan) Budgeting (Resource Plan) Management Process Management Review / Audit Customer Order Resource Allotment Production / Service Planning Satisfaction

Dispatch

Production
Marketing

Core Process

Material / Production / Service / testing

Material service procurement / storage

Annexure:6.1

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Document No. SMF/01/01 7.0 PERSONNEL

TITLE: Personnel EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 10 of 35

(a) ORGANISATIONAL CHART SHOWING THE ARRANGEMENTS FOR QUALITY ASSURANCE INCLUDING
PRODUCTION & QUALITY CONTROL

: Managing Director

HIERACHICAL CHART

Plant Head

Q.C In Charge

Q.A In Charge / Management Representative

Production In Charge

Engineering In Charge

Store In Charge

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Document No. SMF/01/01

TITLE: Personnel EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 11 of 35

(b) QUALIFICATION, EXPERIENCE & RESPONSIBILITIES OF KEY PERSONNEL :

Sr. No. (A) 1 2 (B) 3

Name of Person

Qualification

Experience 8 yrs 18 yrs 16 yrs

Department Mfg. Section Mfg. Section Chemical and Physicochemical Section

Approval / Unapproved Approved Approved Approved

MANUFACTURING SECTION Mr. Rajesh B.Pharm Makanwal Mr Ram lal B.Sc. Prajapati QUALITY CONTROL SECTION Mrs. Jahanvi Rao M.Sc.

Number of employees to be engaged in production, quality control, storage and distribution. Production Dept. : 10 Quality control & Assurance Dept. : 06 Store ( RM, PM & FG) : 04 P & A Dept. : 03 Maintenance Dept. : 03 Account Dept. : 02

Total

28

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TITLE: Personnel EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 12 of 35

(c) OUTLINE FOR ARRANGEMENT FOR BASIC AND IN SERVICE TRAINING AND HOW RECORDS ARE MAINTAINED : All employees will have to go through training as per annual training plan. Training on GMP will be on-going process and all the employees will be regularly trained to increase their awareness of current requirements. Immediate outside experts & superior impart through training for all departmental. The employees are subjected to oral & written quarries. The training records will be maintained for all employees. (d) HEALTH REQUIREMENT FOR PERSONNEL ENGAGED IN PRODUCTION : Administrative head is responsible for arranging the medical checking of employees through a qualified physician. Medical examination is carried out by company approved physician every year or in between if required. For any unusual findings during the check up physician advises the person affected. During the treatment period suitable reallocation of job is done. Rechecking is done following approved guidance & frequently, and after the person is certified medically fit, he is put on his original job. (e) PERSONNEL HYGINE REQUIRMENTS, INCLUDING CLOTHING : The company provides change rooms for changing company uniforms including shoes. The employees working in production area change their shoes and wear factory footwear, along with factory uniforms & cap. The employees in other areas like Quality control will wear aprons and laboratory slippers. The employees in engineering department wear suitable shoes and factory uniforms. All the employees have been instructed about dress code and to change the dress every other day. Other aspects of personnels hygiene like daily bath, hair & nail cut.

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Document No. SMF/01/01 8.0 PREMISES

TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 13 of 35

(a) LAYOUT PLAN OR DESCRIPTION OF MANUFACUTRING AREA : Sr. No. 1. 2. 3 4 3. 4. Sr. No. 1. 2. 3. 4. 5. 6 7 8 9 10 11 Area Ground floor First floor Second floor Service Area Utility Block D.G.Set Area Sr. No. 1. 2. 3. 4. Type of area finishing RCC Roof, Kota Stone & Flush doors. RCC Roof, Kota Stone & Flush doors. Vetrified tiles in Q.C Area RCC roofs & Covered with fancy hood RCC Floor RCC Floor First floor Area GeneralProduction General Packing Approved R.M Store Approved P.M Store Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. Second floor Area Incubator Chemical section Retain sample Record room Stability chamber Q.C.Office Micro testing Media prepn Room Instrument Room

Ground floor Area MD & Adm. Office Warehouse Change room Toilet R.M.Store HormonalProduction Security office Visitors Rooms Hormonal Packing Utility Block D.G & Pannel Area

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Document No.

TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE

PAGE No.

SMF/01/01 01.10.2009 30.09.2010 14 of 35 Canteen & toilet is not directly attached with production area. Plant layout design & equipment is as per the revised schedule-M requirement. (b) NATURE OF CONSTRUCTION & FIXTURES / FITTINGS : Building: The building is made up of RCC construction and all the processing areas from inside are having smooth wall painted with oil paint/oil bound emulsion paint. Utility: Manufacturing equipments are provided power supply back up with DG set, which is bale to restore DG power within 2 minutes. The critical QC instruments are also provided with stabilizer. Aluminum doors & Windows: The doors and windows are designed very carefully to have a minimum number of horizontal surfaces. The sills of the windows are sloping. The windows are kept flush with the plaster inside manufacturing areas and gap between aluminum and masonry are sealed with scaling. Floor: Flooring is made up of mirror polished Kota stone. Coving: Coving is provided in all production areas at the junction of wall to floor, wall to wall to ceiling and are painted with washable paint. Fall ceiling: Fall ceiling in the air-conditioned areas is of plaster of paris sheets. The sheets is fixed with double layered arrangement and the joints of the upper layer and lower layer of the board are so arranged (staggered) that there is no leakages of air. All entrances and major doors are provided with air lock and air curtains wherever required. The sanitary fittings are connected and drainage system is under ground and provided with trapped gullies. S.S Light S.S-304 riser Both Side Stair & Well Equipped Lift provision

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TITLE: Premises EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 15 of 35

(d) SPECIFIAL AREAS FOR THE HANDLING OF HIGHLY TOXIC, HAZARDOUS & SENSITIZING MATERIALS: Not Applicable, as presently we do not use such type of materials. (e) BRIEF DESCRIPTION OF WATER SYSTEMS (schematic drawings of systems) : Copy attached Total 4 sampling points are provided for water system monitoring, cleaning, sanitation and validation plan is followed as per standard operating procedures, water log book & water validation file. (f) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMMES FOR PREMISES AND OF THE RECORDING SYSTEM : More emphasis is given on the preventive maintenance program of plant utility services, machines etc. Maintenance department is equipped with highly qualified and experienced engineers and technicians. Maintenance as well as plant operators are provided through training at machine manufacturing site for knowing its operation, use, accuracy, efficacy etc. Installation qualification & performance qualification of every new machine is carried out. Calibrations are done frequently. The logbooks are maintained for all critical equipments. Whenever necessary, help of outside maintenance consultants is taken to maintain facilities such as Air handling units, laminar air flow, pest control etc. routines as well as periodical maintenance are scheduled and documented. For recording system computer validation system is followed.

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Document No. SMF/01/01

TITLE:VENTILATION SYSTEM & UTILITIES EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 16 of 35

SR. NO.

DESCRIPTION

AIR HANDLING UNITS HOREMON-Ground Floor AHU-1-4000CFM-65mm- 8TR[Grenulation] AHU-2-600CFM-65mm- 1.5 TR[Sampling/Dispensing] AHU-3-600CFM-65mm- 1.5 TR[TIB] AHU-4-1200CFM-65mm-3TR[Blister Pack] AHU-5-800CFM-65mm-2TR[Strip Pack] AHU-6-800CFM-65mm-2TR[Compression] AHU-7-1200CFM-65mm- 3TR[Coating] AHU-8-3200CFM-65mm- 6TR[Corridor & Misc.] AHU-9-600CFM-65mm-1.5TR[Sampling] AHU-10-800CFM-65mm- 2TR[Blending] AHU-11-600CFM-65mm- 1.5TR[Sampling]

General Tablets-First Floor AHU-12-4800CFM-65mm-10TR[Granulation] AHU-13-1200CFM-65mm-3TR[Blending] AHU-14-1200CFM-65mm- 3TR[Coating-1] AHU-15-1200CFM-65mm- 3TR[Compression-1]

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AHU-16-800CFM-65mm- 2TR[Compression-2] AHU-17-600CFM-65mm- 1.5TR [TIB] AHU-18-600CFM-65mm- 1.5TR[Dispensing] AHU-19-1200CFM-65mm-3TR[Blister-1] AHU-20-1200CFM-65mm-3TR[Blister-2] AHU-21-800CFM-65mm- 2TR[Strip Packing] AHU-22-3200CFM-65mm-6TR[Corridor & Misc.] AHU-23-1200CFM-65mm- 3TR[Coating-2] Quality Control-Second Floor AHU-24-600CFM-65mm-1.5TR[ Micro Q.C.] 2 Forcd Draft Ventillation Supply Air System[GROUND FLOOR] FDVS-1:2000-20[Gen.Ch.Room] FDVS-2:1000-50[Hormon Ch.Room] FDVS-3:1000-20[Hormon PMS] FDVS-4:1000-20[General PMS] FDVS-5:3000-20[Misc. Q.C.Area]

Forcd Draft Ventillation Exhaust Air System[GROUND FLOOR] FDVE-1:1000-20[Gen.Ch.Room-First floor] [Not Require as Room Exhaust-Hormon] FDVE-3:1000-20[Hormon PMS] FDVE-4:1000-20[General PMS] [Not Require as Room Exhaust-Q.C]

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Refrigeration Type Dehumidifire 1 TR 2 TR

OTHER UTILITIES[GROUND FLOOR] 5 Air Compressor-1 Air Compressor-2 6 7 8 9 Compressed Air Dryer D.M Water Plant D.M Water Plant ETP

Split A.C Misc. Stores[GROUND FLOOR] R.M.Approved Store Horemone F.P.S Secondary Packing Hall General FP Stores Director's Office Reception

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Manager Office Staff Office

Split A.C

RM Stores[FIRST FLOOR] Approved RM[14a] ALU.PVC Store[14b]

Split A.C Misc. Areas[SECOND FLOOR] Q.C.Manager Critical Instrument Room General Instrument Room Retain Sample Room

Minimum 20 air changes are provided in all production area, supply filter are having 5 porosity & return filter are having 20 porosity. Minimum 0.5mm pressure difference is kept in different categories of production area with maximum positive pressure kept in filling & sealing area. Refer plan layout Annexure 1 for more details.

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Document No. SMF/01/01 4.0 EQUIPMENT

TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

PAGE No. 20 of 35

(a) BRIEF DESCRIPTION OF MAJOR EQIPMENT USED IN PRODUCTION & CONTROL LABORATORIES :

General Tablets
NAME OF MACHINE SUPPLIER CAPACITY ELE. LOAD H.P 14.0 1.0 28.0 5.0 3.0 3.0 7.0 0.7 3.0 36 27 STN (D TOOLING) 27 STN (D TOOLING) 150 CFM 7.0 5 .0 5 .0 1.50 150 AIR QTY(CFM) 100 10 PRESSURE(K G) 6.0 kg 6.0 kg

FLUID BED DRIER VIBRO SIFTER R.M.G PASTE KETTLE MULTIMILL LUBRICATION OCTAGONAL BLENDER COATING-1 COATING PAN SOLUTION PREPARATION TANK COLLOID MILL COATING-2 COATING PAN COMPRESSION ACRA-B4-27-D ACRA-B4-27-D DUST EXTRACTOR-1

TECHX TECHX TECHX TECHX TECHX TECHX TECHX TECHX TECHX TECHX FLUIDPACK FLUIDPACK FLUIDPACK

60 KG 36 150 LTR 100 LTR 250 KG/HR 300 LTR 36 50 LTR

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DUST EXTRACTOT-2 DEBURRING&DED USTING UNIT 4 NO. PACKING BLISTER ALU-ALU CONVEYOR BELT-1 CONVEYOR BELT-2

FLUIDPACK F.P MACHINERIES

150 CFM

1.50 2.0

150

KULBINDRA P.G

9.0 9.0 1.0 1.0 HORMONAL SECTION

150 150

6.0 kg 5.0 kg

GRANULATION SECTION FLUID BED TECHX DRIER VIBRO SIFTER TECHX R.M.G TECHX MULTIMILL TECHX LUBRICATION OCTAGONAL TECHX BLENDER COATING-1 COATING PAN TECHX SOLUTION TECHX PREPARATION TANK COMPRESSION ACRA-B4-27-D FLUIDPACK DEBURRING&DED USTING UNIT 4 NO. DUST EXTRACTOR-1 PACKING BLISTER STRIP CONVEYOR BELT-1 CONVEYOR BELT-2 D.G. SET F.P MACHINERIES FLUIDPACK KULBINDRA KULBINDRA

10 KG 12 25 LTR 50 LTR 24 50 LTR

8.0 0.5 5.0 2.0 1.5 5.0 0.7

27 STN (D TOOLING

5.0 1.0

150 CFM 8.80 3.5 1.0 1.0 150 4.0 kg

SUDHIR GENSET

200 KVA

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AIR COMPRESSOR AIR DRIER R.O.PLANT E.T.P PLANT

KAILA ENGIN KAILA ENGIN ARYATECH MAINSA ENGG. WORKS 1000 LTR/HR 3000-5000 LTR

10.0 2.0 7.0 7.0

A.H.U

DYNAFLOW

250.0

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Document No. SMF/01/01

SR.NO. 1 2 3 4 5 6 7 8 9 10

TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

MAKE Waters Shimadzu MODEL NO, 515 UV-1800

PAGE No. 23 of 35

NAME HPLC UV spectrophotometer Analytical Balance pH meter Abbe refractometer Polarimeter KF apparatus UV cabinet Melting point apparatus(digital) Potentiometer/Autotitrator

SPECIFICATION Isocratic system Std.

CHEMICAL SECTION
SR.NO. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 NAME OF LABORATORY INSTR. Vaccum oven Sonicator Mechanical flak shaker Water bath Universal oven Muffle furnace Heating mantle Hot plate with stirrer Dist. Water app. (wall mounted)s.s TLC kit Bulk density appa.(Tapping type) Dissolution test appa. 8 baskets Leak test appa. Friability appa.(digital rpm counter) Hardness tester IR moisture balance Centrifuge machine Vortex mixer MAKE MODEL NO, SPECIFICATION

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SR.NO. 1 2 3 4 5 6

NAME OF LABORATORY INSTR. Microscope Autoclave Bacteriological incubator BOD incubator Colony counter(digital) Laminar Air Flow bench

MAKE

MODEL NO,

SPECIFICATION

Popular

Horizontal

(b) DESCRIPTION OF PLANNED PREVENTIVE MAINTAINANCE PROGRAMS FOR EQUIPMENT & OF THE RECORDING SYSTEM : As mentioned in point planned preventive maintenance exists and the records are maintained for preventive maintenance and major breakdown of equipment and machine. (c) QUALIFICATION & CALIBRATION INCLUDING THE RECORDING SYSTEM AND ARRANGEMENT FOR COMPUTERIZED SYSTEMS VALIDATION : Periodic calibration / validation of equipments / process / Utilities / system / personnel are carried out and records are maintained. For certain equipments and utilities validation is carried out periodically by the standard external agencies. Calibration / validation schedule protocol is as per calibration / validation Index . It is audited in self-inspection. Written standard operating procedures are laid for cleaning of manufacturing areas and equipments. For area cleaning two type disinfectants are used fortnightly alternatively. Review of standard operating procedure is made at every three years and any correction / deviation is properly recorded after getting authorization from Q.A. as per procedure of document & data control. Pest control of the entire plant is maintained through administration department with the help of outside agencies.

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Document No. SMF/01/01

TITLE: Equipment EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010 List of Calibration of Equipments / Instruments

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Sr.No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Item Pest Control Medical Checkup of Employee Aseptic Filling (Media Fill test) Filter Integrity Testing Manufacturing tank pH Meter Single Pan Balance Plate form Balance Spectrophotometer Auto clave Dry heat sterilizer Aseptic Area U.V. Light Thermometer Glass equipment Normality Testing Pressure/Temp.gauges/Hygrometer Hepa filters Product Stability studies Inter Department Audit Melting point Apparatus Karl Fischer apparatus

Frequency of Calibration/ Validation Yearly Yearly Yearly Batch wise At the time of purchase Daily Daily/ Yearly Daily/ Yearly Monthly Daily/Quarterly Daily/Quarterly Daily Quarterly At the time of use At the time of purchase At the time of use Yearly Yearly As per individual product Quarterly Monthly At the time of use

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Document No. SMF/01/01

TITLE: Sanitation / Documentation EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

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11.0 SANITATION (a) AVAILABILITY OF WRITTEN SPECIFICATION & PROCEDURE FOR CLEANING MANUFACTURING AREA & EQUIPMENT : Sanitation of entire plant, surrounding and manufacturing area is being done as per area cleaning SOPs Efficacy of Disinfectant solutions is validated microbiologically. HVAC system & water system is also continuously sanitized and the same is recorded in utility logbook. Validation of the equipment cleaning will be done as per master validation plan. 11.A DOCUMENTATION (a) a. b. c. d. e. f.

ARRANGEMENT FOR THE PREPARATION, REVISION & DISTRIBUTION OF NECESSARY DOCUMENTATION FOR MANUFACTURE: Well-defined system exists for in warding, storage and issue of raw & packing materials. Raw & packing materials are sampled and approved by Quality Control department. Batch manufacturing records (BMR) for every product and every batch is issued by quality assurance to production department. In process checks at regular intervals are carried out with proper documentation by Q.A. All manufacturing operation is followed as per instructions given in BMR and entail heads before submission to Q.A. for final approval of the batch. Before final dispatch of every batch, Quality assurance department verifies BMR along with certificate of analysis and release slip is issued.
Solitaire Pharmacia Pvt. Ltd. maintains documents regarding: Standard Operating Procedure & its related records. Site Master file Specification of all Materials & Finish products Test procedure & protocol Master formula card Batch production & control records Disposal records Release records & distribution records Calibration / Validation records Quality management system related documents

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Document No. SMF/01/01

TITLE: SANITATION & Documentation EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

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Standard operating procedure are prepared for each and every operation and are authorized for all the departmental activities and strictly followed. All minor changes in the documents are recorded in the same records by recalling copies from all departments for authorization by QA head with date of correction. For major changes entire documents are replaced with amendment copy and old copies are destroyed except one kept with QA department with cancellation. A detail of documents withdrawal / distribution will be kept with QA department under document and data control index. Necessary document related to manufacturing such as Master formula card and Batch manufacturing & its associated record are maintained and issued by Q.A.department. (b) ANY COPY OTHER DOCUMENTS RELATED TO PRODUCT QUALITY THAT IS NOT MENTIONED ELSEWHERE : (E.G. MICROBIOLOGICAL CONTROLS IN AIR & WATER) Following methods are followed as per well-defined schedule: Microbial counts and limit tests for bore well, DM water and finished products. Manufacturing, filing & sealing areas environmental monitoring by setting plat count.

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TITLE: Production EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

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7.0 PRODUCTION (a) BRIEF DESCRIPTION OF PRODUCTION OPERATIONS : Production operation is explained by way of flow chart describing movement of material & movement of batch manufacturing record. Refer Annexure 6.1 attached. (b) ARRANGEMENTS FOR THE HANDLING OF STARTING OF STARTING MATERIALS, PACKAGING MATERIALS & BULK & FINISHED PRODUCTS INCLUDING SAMPLING, QUARANTINE, RELEASE & STORAGE : Each consignment of material received is examined visually and damaged goods are kept separate and inform to quality control person for further instructions for disposal or return goods to party. On verification of quantity received and making batch wise segregation identification number is given serially. All the containers are labeled UNDER TEST with details such as name, inward number, quantity, no. of containers, manufactures name, material code no. and put material in to the quarantine area. Samples are drawn as per sampling plan & tested in detail as per specification by quality control. On completion of tests Q.C. decided whether the material is approved or rejected and accordingly if material is approved, APPROVED label are fixed and material is transferred to approve material storage area. If material rejected than transfer to rejected area (Flow chart of Movement of material is enclosed). All packing materials are stored securely under lock & key and issued in requisite number only. At various places of operation separate areas are created so that the material or product is held on Under Test, Approved, Rejected or Quarantine area etc. All raw materials are transported in closed labeled containers or properly labeled sealed plastic bags. The Quality Assurance instructions are followed for material status. All weighing balance are regularly calibrated.

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(c) ARRANGEMENTS FOR THE HANDLING OF REJECTED MATERIALS & PRODUCTS : For all rejected materials, the materials are separated from other Approved or Under Test lots and Rejected labels are affixed by the Quality control persons. The rejected material is transferred to a separate Rejected materials area. Quality assurance decides the fate of such rejected materials as to destroy, reprocess or to refer to the supplier. (d) BRIEF DESCRIPTION OF GENERAL POLICY FOR PROCESS VALIDATION : Process validation is as per documented program (master validation plan), which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes. We follow the following systems with regard to process validation: Establish specification and performance criteria. Select methodology, process & equipment to ensure the product meets with the specification. Test the final product using validated analytical methods in order to meet specification.

Following steps supports the above steps: Calibration, verification and maintenance of process equipments. Qualification of both process & equipment. Challenge, audit, monitor or sample the recognized critical or key steps in the process. And finally when there is a significant change in the product or process, Re-qualify or revalidate the process.

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Document No. SMF/01/01

TITLE: Quality Control EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

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SHORT DESCRIPTION OF THE QUALITY MANAGEMENT SYSTEM OF THE FIRM The company believes in total quality management system and constantly upgrading standards of specification of its products & services. The quality policy states as under,

We at Solitaire Pharmacia Pvt Ltd are Committed, To supply Quality medicines at competitive rates & Service to Satisfy our Customer. To follow prevailing National & International Standards of Pharmaceutical Industry.

To continually improve our Quality Management System with Continual Training & Collective Wisdom.

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Quality has been the most prime consideration in recruitment of manpower. Our organization chart explains the hierarchical levels of the organization. For strengthening the system, following activities are carried out by Pharma consultants. The in-house training programme covers all relevant aspects of cGMP. Testing as per well defined specification control the input materials and release procedures for semi finished and finished products exit. Production as well as Quality assurance monitors quality by carrying out in process testing during various stages of manufacturing. Standard operating procedures are available for different operations. Products are manufactured as per procedure given in batch manufacturing records and recorded accordingly. Standard validation/calibration protocols adhered for validation of all critical equipments processes/instruments/products/system/utilities etc. Master formula records, which are prepared for individual products, are adhered in batch manufacturing & testing processes. Maintenance history records are maintained for critical instruments and equipments to ensure proper preventive maintenance. The assessment of effectiveness of QMS is done by periodic self-inspection & management review meeting. a. Incoming material Quality b. Product Quality c. Compliance with systems / document control d. Customer complaints e. Corrective action to avoid non-conformity f. Internal Quality Audits

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QUALITY CONTROL (a) DESCRIPTION OF QUALITY CONTROL SYSTEM AND OF THE ACTIVITES OF THE QUALITY CONTROL / QUALITY ASSURANCE DEPARTMENT PROCEDURE FOR THE RELEASE OF THE FINISHED PRODUCTS : Quality assurance & Quality control department combines activities performed are as follows. Specification of raw material, Packing material & Finished products are prepared, standardized & pharmacopoeia guidelines are followed for the same. Outside help is procured for developing in-house specification in area where pharmacopiea specifications do not exist. Methods for reagent standardization and instrument calibration / validation are defined and being followed. Procedure for the release of raw material and finished products are defined and being followed as per the standard procedure and the norms down in pharmacopiea or by developing in-house specification. Company is having well-equipped Quality control laboratory having Physico-chemical instrumentation and microbial testing. Laboratory facilities with necessary retain sample and documentation storage area. All well define procedures for finished product analysis are followed and finished product release for the market after complete testing. The store dispenses the materials in presence of Q.A. person against bill of materials issued. The dispensed materials carry appropriate labeling. Manufacturing activities are started as per Batch manufacturing record. In-process checks are carried out by production and Q.A. independently. Coded packing materials are checked by production and Q.A. for the correctness of batch coding details. The packing department reconciles the printed packing materials. Batch production records are reviewed by production and Q.A. and yield data are reconciled by production and Q.A. Q.A.department also approves transfer of finished product to finished product store for sale. Q.A. maintains control samples of raw material and finished products. Stability studies are carried out by Q.A. SOP compliance and GMP implementation is monitored by Q.A.

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TITLE: Distribution, Complaints & Product recall Document No. EFFECTIVE DATE NEXT REVIEW DATE SMF/01/01 01.10.2009 30.09.2010 10.0 DISTRIBUTION, COMPLAINTS & PRODUCT RECALL

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(a) ARRANGEMENTS AND RECORDING SYSTEM FOR DISTRIBUTION : Finished goods will be transferred from packing department to finished goods stores with transfer note, after getting final release for sale from Q.A. department. For each batch of the final product distribution records are available with dispatch department inside the factory premises (b) ARRANGMENTS FOR THE HANDLING OF COMPLAINTS AND PRODUCT RECALLS : On receipt of quality complaints from the customer, Informed to Q.A. department for the same Q.A. department will recheck retain samples and records for the same. Q.A. will send investigation report to customer through M.D. In case of critical complaints decision for recalling the product will be taken by top management and is communicated to distribution manger. Distribution manager will recall the products as per product recall SOP. Suggestion / complain register for all complaints / suggestions of external / internal origin will be maintained & same is reviewed in management review meeting.

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Document No. SMF/01/01 11.0 SELF INSPECTION

TITLE: Self Inspection EFFECTIVE DATE NEXT REVIEW DATE 01.10.2009 30.09.2010

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(a) SHORT DESCRIPTION OF SELF-INSPECTION SYSTEM : The self inspection system is based on the Standard Operating Procedure on cGMP requirements covering the following items. a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. Personnel Premises including personnel facilities Maintenance of building & equipments Storage of starting materials 7 finished product Equipments Production & In-process controls Quality control Documentation Sanitation & hygiene Validation & revalidation program Calibration of instruments or measurement systems. Recall procedures. Complaint management Labels control Results of previous self-inspection & corrective steps taken

QA head will appoints a self-inspection team from local staff, who are expert in their own field and with cGMP & if required,outside expert will be retained by us. This self-inspection will be done once in six month with the help of outside expert. A report will be made after compliance of the self-inspection, which includes, 1. 2. 3. Self-inspection results Correction & root cause analysis Recommended corrective actions.

The company management evaluates both the self-inspection report and the corrective action as necessary.

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QUALITY POLICY
SOLITAIRE PHARMACIA PVT LTD IS COMMITTED TO ACHIEVE
QUALITY STANDARDS USING NATIONAL & INTERNATIONAL NORMS WITH CONTINUOUS IMPROVEMENT IN PRODUCTS AND SERVICES FOR ULTIMATE SATISFACTION OF ALL OUR VALUED CUSTOMERS.

SOLITAIRE PHARMACIA PVT LTD IS DEDICATED TO LIFE AND

QUALITY IS A WAY OF LIFE AT SOLITAIRE PHARMACIA PVT LTD

MANAGING DIRECTOR

( Sanjeev Kumar Sethi )

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