Pharmaceutical CGMP Guidelines Water Sampling Procedure

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Water sampling procedure

1.0 PURPOSE

To lay down the procedure for sampling of water for Microbiological and Chemical analysis. 2.0

SCOPE

This is applicable to quality control department. 3.0 RESPONSIBILITY Microbiology personnel 4.0 PROCEDURE 4.1

Sampling of water for Microbiological analysis 4.1.1

Before sampling ensure that the sampling kit is available as per the details mentioned in Annexure – III.

4.1.2

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Note: The schedule shall be prepared before start of particular month. 4.1.3

Samples for microbiological evaluation should be collected in Pre-sterilized screw cap glass bottles. 4.1.4

For sampling of Treated Raw water (May contain chlorine), add 0.1 ml of 5 % Sodium Thiosulphate solution in the bottles before sterilization.

Note: Before sampling, the aluminium foil covering the sampling point should be removed. 4.1.5

Wear the sterile hand gloves and remove the cap of the bottle just prior collecting the sample. 4.1.6

The "sample contact area of cap" should not come in contact with any surface, including the fingers or hands of the individual collecting the sample.

4.1.7

The cap may be set on the top of a clean surface, topside against the surface. 4.1.8

Open the sampling/user point valve until there is a steady stream of water. 4.1.9

Drain for approximately 1 minute, collect water in sampling bottle. 4.1.10

Do not allow the ‘bottle’ or the ‘water in the bottle’ to come in contact with the valve. 4.1.11

Fill the bottle without overflowing the bottle. 4.1.12

Remove the bottle from the sample stream and place the cap on the bottle as quickly as possible. 4.1.13

Tighten the cap securely. 4.1.14

Close the valve. 4.1.15

Fill the information on the face of the bottle such as location of sampling, date of sampling and signature.

4.1.16

Collect all samples as per the Annexure-II and Proceed for analysis as per the SOP. If the samples are not taken immediately for analysis store it at refrigerator (2-8°C).

4.1.17

Ensure that analysis is initiated within 24 hrs after sampling.

4.2

Sampling of water for Bacterial Endotoxin Testing 4.2.1

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Samples for bacterial endotoxin test should be collected in depyrogenated vials covered with aluminum foil.

4.2.2

Remove the aluminum foil from the vial immediately prior to collecting the sample. 4.2.3

The "sample contact area of aluminium foil" should not come in contact with any surface, including the fingers or hands of the individual collecting the sample.

4.2.4

The foil may be set on the top of a clean surface, topside against the surface. 4.2.5

Drain for approximately 1 minute, collect water in sampling vial. 4.2.7

Do not allow the ‘vial’ or the ‘water in the vial’ to come in contact with the valve. 4.2.8

Fill the vial, without overflowing the vial. 4.2.9

Remove the vial from the sample stream and place the aluminium foil on the vial as quickly as possible.

4.2.10

Cover the vial with aluminium foil after sampling. 4.2.11

4.2.13

4.2.14

Ensure that analysis is initiated within 24 hrs after sampling. 4.3

Sampling of water for Chemical analysis 4.3.1

Samples for chemical analysis should be collected in a clean and dried bottle. 4.3.2

Remove the cap from the bottle just prior to collect the sample. 4.3.3

The sample side of the cap should not come in contact with any surface, including the finger or hands of the individual obtaining the sample.

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4.3.4

The cap may be kept on the top of a clean surface, topside against the surface. 4.3.5

Drain for approximately 1 minute, Collect water in sampling bottle. 4.3.7

Rinse the bottle with the water to be sampled at least three times. 4.3.8

Do not allow the bottle or the water in the bottle to come in contact with the valve. 4.3.9

Fill the bottle and remove the bottle from the sample stream and place the cap on the bottle as quickly as possible and ensure that no air bubble is entrapped.

4.3.10

For TOC analysis collect the sample in the separate vials/bottles. Collect the sample by over flowing the vials and close with the lid/cap immediately.

4.3.11

4.3.13

4.3.14

Ensure that the analysis is in any case is initiated within 24 hrs after sampling. 4.4

Shipment 4.4.1

If a contract laboratory is utilized, samples shall be sent by express service to arrive at the contract laboratory.

4.4.2

Sample container transfer "boxes" should include provisions for maintaining the sample temperature below 25°C at any time.

4.4.3

Samples should not be frozen or cooled to a temperature < 2°C. 4.5

Numbering of test data sheet. Where,

4.5.1

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Y = Last digit of current year. XX = Code number of water type

such as (Raw water-RW, Soft water-SW, Potable water -DW, Drinking water-DR, RO water-RO, Purified water-PW, Water for injection-WF, Pure steam-PS).

NNNN = Serial No. starting from 0001. 4.5.2

Allot the test data sheet number in Annexure-I in remark column. 4.6

Document numbering of test data sheet Where,

4.6.1

Document numbering of test data sheet is as follow TDS/XX/00N TDS = Test data sheet

XX = Code number of water type

such as (Raw water-RW, Soft water-SW, Potable water-DW, Drinking Water-DR, RO water-RO, Purified water-PW, Water for injection-WF, Pure steam-PS).

NNN = Serial No. starting from 001. 5.0

ABBREVIATIONS AND DEFINITIONS

SOP Standard Operating Procedure QCM Quality Control Microbiology QAD Quality Assurance Department REV. Revision No. Number % Percent mL Milli litre °C Degree Centigrade hrs Hours

TOC Total Organic Carbon RW Raw Water

SW Soft Water DW Potable water DR Drinking water PW Purified Water WF Water for Injection PS Pure steam

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Regulatory Guidelines

 ISO Guidelines  WHO Guidelines  US-FDA Guidelines  ICH Guidelines  MHRA-UK Guidelines

 MCC Guidelines -South Africa

 TGA Guidelines-Australia  MCA Guidelines-Zimbabwe  Schedule M-India  European Guidelines

 MEDSAFE Guidelines -Newzeland

 GCC Guidelines -Gulf

 PDMA Guidelines -Japan

 PANDRH Guidelines -American

 PIC/S Guidelines

 IPEQ Guidelines

 Drugs & Cosmetics Act-India

 APIC Guidelines

 EU Guidelines

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SOP For Operation And Calibration Of Water Bath

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SOP For Operation And Calibration of Auto Titrator (Metrohm)

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SOP For Operation And Calibration of Sieve Shaker

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SOP For Operation Of Milli- Q Water System

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SOP For Operation Of UV Cabinet

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SOP For Operation of Bacteriological Incubator

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SOP For Operation of HPLC System Using Chemistation Software

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SOP For Preparation And Standardisation Of Volumetric Solution

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SOP For Preparation of Culture Of Microorganism

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SOP For Safety Measurs of QC Laboratory

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SOP For Storage Of Sampling Tool

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SOP For Validation Of Autoclave With Biological Indicator For Sterilization

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SOP For handling of market complaints

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SOP for Antimicrobial effectiveness testing

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SOP for Cleaning and Operation of Anaerobic Culture Jar

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SOP for Cleaning of Glassware

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SOP for Deaeration of Dissolution media

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SOP for Disposable of mediafill vials after incubation

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SOP for Entry and Exit procedure for microbiology testing area and Sterility

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SOP for Identification of microbial cultures using biomeriux identification system

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SOP for L.O.D. oven

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SOP for Operation and Calibration of Top Pan Balance

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SOP for Operation and Cleaning of Garment Cubicle

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SOP for Operation and Cleaning of Vertical Portable Autoclave

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SOP for Operation and Maintenance of Sterilization Reel Sealer

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SOP for Operation and Performance qualification of Biomerieux Kit (mini API,

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SOP for Operation of Rady Count Down Timer

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SOP for Personnel Qualification of personnel entering into Aseptic area and

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SOP for Post Sterility Growth Promotion Test

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SOP for Preparation of Trends

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SOP for Procedure For Bioburden, BET, And LPC Of Primary Packaging Materials

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SOP for Procedure for Bacterial Endotoxin (LAL) test

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SOP for Procedure for Die Blocking

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SOP for Procedure for Handling of Out Of Limit Results in Environmental

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SOP for Procedure for Operation of Deduster Cum Metal Detector

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SOP for Procedure for Receipt of Raw and Packing Material

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SOP for Procedure for Storage and Preparation of Microbiological Culture Media

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SOP for Procedure for preparation of dresses for sterilization.

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SOP for Sampling and Testing of Pure Steam

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SOP for Sterility Testing Using Manifold For Dilution Study and Stability

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SOP for Swab sampling for validation of test surface to evaluate cleaning efficacy.

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SOP for Testing of Particulate Matter in Injections and Operation and Maintenance

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SOP for allocating identification number to instrument/ equipment

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SOP for bacteriological incubator

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SOP for calibration of Autotitrator

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SOP for calibration of balance

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SOP for calibration of disintegration test apparatus

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SOP for calibration of hardness tester

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SOP for calibration of infrared moisture balance

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SOP for calibration of karl fischer apparatus

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SOP for calibration of plunger operated pipette

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SOP for calibration of refractometer

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SOP for calibration of the refractometer

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SOP for calibration of walk-in- incubators 20-25°c and 30-35°c

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SOP for calibration procedure of u.v.cabinet

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SOP for careful handling of poisonous chemicals

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SOP for check suitability of dissolution test apparatus

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SOP for cleaning and disinfection

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SOP for cleaning and operation of RLAF unit in Sampling Room

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SOP for cleaning and operation of incubator

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SOP for cleaning for DHS

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SOP for cleaning of Dispensing & Sampling Room

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SOP for cleaning of Metrohm Karl fisher

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SOP for cleaning of Vertical Autoclave

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SOP for cleaning of automatic distillation apparatus

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SOP for cleaning of colony counter

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SOP for cleaning of disintegration test apparatus

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SOP for cleaning of dissolution tester

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SOP for cleaning of friability test apparatus

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SOP for cleaning of melting point apparatus

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SOP for cleaning of oven for incubator at 55°c

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SOP for cleaning of slit to agar air sampler

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SOP for cleaning of tablet hardness tester

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SOP for cleaning procedure for Alu-Alu Packing Machine

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SOP for cleaning procedure for Dehumidifier

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SOP for cleaning procedure for EPD Collator machine with strip packing machine

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SOP for cleaning procedure for FBD Bag

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SOP for cleaning procedure for Hose Pipe Of Dust Extraction System

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SOP for cleaning procedure for Mini roll compactor

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SOP for cleaning procedure for Paste Kettle

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SOP for cleaning procedure for Rapid Mixer Granulator (R.M.G.)

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SOP for cleaning procedure for Semi-Automatic Cartoning Machine

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SOP for cleaning procedure for Vacuum Cleaner

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SOP for cleaning procedure for brooke field viscometer

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SOP for cleaning procedure for centrifuge

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SOP for cleaning procedure for heating block

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SOP for operating procedure of culture cabinet

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SOP for operating procedure of double door autoclave

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SOP for operating procedure of laminar air flow

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SOP for operation and calbration of dry bath

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SOP for operation and calibration of bursting strength tester

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SOP for operation and calibration of pH meter (GMPH)

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SOP for operation and calibration of tablet disintegration apparatus

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SOP for operation and cleaning of LAF unit in Sampling Room

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SOP for operation and monitoring of performance of garment cabinet

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SOP for operation of magnetic stirrer with hot plate

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SOP for operation of particle counter

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SOP for operation of sonicator

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SOP for operational check of friability test apparatus

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SOP for oven for depyrogenetion

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SOP for palm swabbing

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SOP for performance check of UV - visible spectrophotometer (Jasco)

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SOP for performance check of autodiluter

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SOP for performance checks of karl fischer apparatus

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SOP for physical monitoring of microbiology section

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SOP for preparation and handling of primary standard

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SOP for preparation of bench reagents

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SOP for preparation of sterile petridishes, agar slants and agar butts

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SOP for procedure environmental monitoring of parenteral processing area : by

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SOP for procedure for DOP testing (Integrity Testing) of HEPA filter

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SOP for procedure for Operation and cleaning of Automatic Batch Printing Machine

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SOP for procedure for Operation of Automatic Capsule Filling Line

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SOP for procedure for Operation of Batch Printing Machine (Semi Automatic)

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SOP for procedure for Operation of Compression Machine 20 station (Single

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SOP for procedure for Operation of Deblistering Machine

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SOP for procedure for Operation of Drum mixer

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SOP for procedure for Operation of Multimill

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SOP for procedure for Operation of Paste Kettle

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SOP for procedure for Operation of Vibro Sifter

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SOP for procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies &

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SOP for procedure for Pre Filter cleaning of RLAF

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SOP for procedure for Receipt, Issuance, Storage and Handling of solvent

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SOP for procedure for Tablet granulation, compression and coating



SOP for procedure for action to be taken during spillage/breakage of materials



SOP for procedure for analyst validation

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SOP for procedure for calibration of instruments



SOP for procedure for carrying out air borne particle count in static condition



SOP for procedure for cleaning and maintenance of boilers



SOP for procedure for cleaning installation, operational and performance

qualification of equipment / instruments.



SOP for procedure for cleaning of barrel pump & pipe



SOP for procedure for cleaning of clean area



SOP for procedure for cleaning of equipment and accessories in Production Area



SOP for procedure for cleaning of microbiological glassware



SOP for procedure for collection and storage of control sample



SOP for procedure for cooling towers



SOP for procedure for destruction of rejected materials



SOP for procedure for electrical safety



SOP for procedure for entering in sterility testing room

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SOP for procedure for environmental monitoring of aspetic area: finger prints and

gown sampling



SOP for procedure for environmental monitoring of parenteral processing area :

surface testing by means of rodac plate and swab



SOP for procedure for fumigation in microbiology lab



SOP for procedure for handling of Rejected Raw Material



SOP for procedure for handling of sieves and screen



SOP for procedure for inspection of pressure vessels, lifts and chain pulley blocks



SOP for procedure for issuance of additional packaging materials



SOP for procedure for maintaining and up-keeping the facility



SOP for procedure for making production related entries in SAP system



SOP for procedure for measurement of air velocity and calculation of air changes

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

SOP for procedure for operation after M.S.E.B. power failure



SOP for procedure for operation and calibration of precision oven



SOP for procedure for operation and maintenance of low tension (L. T.) panels



SOP for procedure for operation of EPD Collator coupled with strip packing

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

SOP for procedure for operation of axial flow fan units (supply and return)



SOP for procedure for operation of conveyor belt in packing



SOP for procedure for operation of high tension (H.T.) panel



SOP for procedure for operation of semi auto induction cap sealing machine



SOP for procedure for operation of the domestic hot water system



SOP for procedure for overprinting of batch details on cartons and catch covers



SOP for procedure for performance of automatic distillation apparatus



SOP for procedure for preparation of reagent solution

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SOP for procedure for preparation of working standards



SOP for procedure for proper disposal of expired finished goods



SOP for procedure for reanalysis of raw material



SOP for procedure for recleaning



SOP for procedure for recording of Temperature & Humidity in Stores Department

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SOP for procedure for recording of Temperature in Production Department



SOP for procedure for return of Raw & Packing materials from production

department



SOP for procedure for safe unloading of chemicals, furnace oil and high-speed

diesel from vehicle inside the factory premises



SOP for procedure for sampling and testing schedule of water for injection and

clean steam



SOP for procedure for sanitization of purified water generation system using hot

water



SOP for procedure for stability studies of finished goods



SOP for procedure for stenciling of shippers used for packing



SOP for procedure for storage & transference of dispensed raw material in day

store



SOP for procedure for temperature mapping

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SOP for procedure for testing and release/rejection of packing materials



SOP for procedure for the Blister Pack Machine



SOP for procedure for the intimation of break down of utilities services &

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

SOP for procedure for the operation of Semi-Automatic Cartoning Machine (VP-120)



SOP for procedure for the passivation of purified water storage tank and

distribution piping



SOP for procedure for transfer of the finished goods to bonded store room



SOP for procedure for validation of microbiologist



SOP for procedure for vessels operated greater than atmospheric pressure



SOP for procedure of fumigation in production area by using 5 % Gramicid and

Fogger



SOP for procedure to specify the responsibilities of production department



SOP for quantification of culture



SOP for receipt and maintenance of working standards of API



SOP for release of finished product



SOP for retesting schedule of packaging material



SOP for retesting schedule of raw material (for API)



SOP for routine cleaning verifictaion by TOC-SSM method



SOP for sampling and release of Inprocess samples



SOP for sampling and testing schedule of purified water



SOP for sampling of packing material



SOP for selection criteria and its procedure before dissolution profile study



SOP for statistical study for trend analysis of purified water and water for

injection



SOP for sterile dress cabinet



SOP for storage and use of reagents & chemicals



SOP for testing for bioburden of fractional solutions



SOP for testing of miscellaneous sample



SOP for training procedure for qc persons



SOP for ultrasonic cleaner



SOP for validation of DHS with biological indicator



SOP for validation of autoclave with biological-indicator



SOP for validation of oven for depyrogeneation.



SOP for verification of system suitability test measured by chrom card software

for GC



SOP for writing method of analysis for P.M

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