pharmaceutical cgmp guidelines water sampling procedure

8/20/2019 Pharmaceutical CGMP Guidelines Water Sampling Procedure

1/17

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Water sampling procedure

1.0

PURPOSE

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

.0

S!OPE

This is applicable to quality control department

".0

R ESPO#SI$I%IT&

Microbiology personnel

'.0

PRO!E(URE

'.1

Sampling o) *ater )or +icro,iological anal-sis

!""

#efore sampling ensure that the sampling kit is a$ailable as per the details mentioned in %nnexure &

'''

!"(

)efer %nnexure '* for the sampling points for a particular day

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2/17

+ote The schedule shall be prepared before start of particular month

!"-

Samples for microbiological e$aluation should be collected in Pre.sterili/ed screw cap glass bottles

!"!

0or sampling of Treated )aw water 1May contain chlorine2, add 3" ml of 4 5 Sodium Thiosulphate

solution in the bottles before sterili/ation

+ote #efore sampling, the aluminium foil co$ering the sampling point should be remo$ed

!"4

6ear the sterile hand glo$es and remo$e the cap of the bottle 7ust prior collecting the sample

!"8

The 9sample contact area of cap9 should not come in contact with any surface, including the fingers

or hands of the indi$idual collecting the sample

!":

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

!";Open the samplingo not allow the ?bottle@ or the ?water in the bottle@ to come in contact with the $al$e

!"""

0ill the bottle without o$erflowing the bottle

!""(

)emo$e the bottle from the sample stream and place the cap on the bottle as quickly as possible

!""-

Tighten the cap securely

!""!

Close the $al$e

!""4

0ill the information on the face of the bottle such as location of sampling, date of sampling and

signature

!""8

Collect all samples as per the %nnexure.'' and Proceed for analysis as per the SOP 'f the samples

are not taken immediately for analysis store it at refrigerator 1(.;AC2

!"":

Bnsure that analysis is initiated within (! hrs after sampling

'.

Sampling o) *ater )or $acterial Endotoin Testing

!("


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Samples for bacterial endotoxin test should be collected in depyrogenated $ials co$ered with

aluminum foil

!((

)emo$e the aluminum foil from the $ial immediately prior to collecting the sample

!(-

The 9sample contact area of aluminium foil9 should not come in contact with any surface, including

the fingers or hands of the indi$idual collecting the sample

!(!

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

!(4

Open the samplingrain for approximately " minute, collect water in sampling $ial

!(:

>o not allow the ?$ial@ or the ?water in the $ial@ to come in contact with the $al$e!(;

0ill the $ial, without o$erflowing the $ial

!(=

)emo$e the $ial from the sample stream and place the aluminium foil on the $ial as quickly as

possible

!("3

Co$er the $ial with aluminium foil after sampling

!(""

Close the $al$e

!("(

0ill the information on the face of the bottle such as location of sampling, date of sampling and

signature

!("-

Collect all samples as per the %nnexure.'' and Proceed for analysis as per the SOP 'f the samples

are not taken immediately for analysis store it at refrigerator 1(.;AC2

!("!

Bnsure that analysis is initiated within (! hrs after sampling

'."

Sampling o) *ater )or !hemical anal-sis

!-"

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

!-(

)emo$e the cap from the bottle 7ust prior to collect the sample

!--

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

hands of the indi$idual obtaining the sample


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!-!

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

!-4

Open the samplingrain for approximately " minute, Collect water in sampling bottle

!-:

)inse the bottle with the water to be sampled at least three times

!-;

>o not allow the bottle or the water in the bottle to come in contact with the $al$e

!-=

0ill the bottle and remo$e 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

!-"3

0or TOC analysis collect the sample in the separate $ials


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D F Gast digit of current year

EE F Code number of water type

such as 1)aw water.)6, Soft water.S6, Potable water .>6, >rinking water.>), )O water.)O,

Purified water.P6, 6ater for in7ection.60, Pure steam.PS2

++++ F Serial +o starting from 333"

!4(

%llot the test data sheet number in %nnexure.' in remark column

'.

(ocument num,ering o) test data sheet

6here,

!8"

>ocument numbering of test data sheet is as follow T>S6, >rinking 6ater.>), )O water.)O,Purified water.P6, 6ater for in7ection.60, Pure steam.PS2

+++ F Serial +o starting from 33"

.0

$$RE2ITIO#S #( (E3I#ITIO#S

SOP Standard Operating Procedure

HCM Huality Control Microbiology

H%> Huality %ssurance >epartment

)B* )e$ision

+o +umber

5 Percent

mG Milli litre

AC >egree Centigrade

hrs Iours

TOC Total Organic Carbon

)6 )aw 6ater

S6 Soft 6ater

>6 Potable water

>) >rinking water

P6 Purified 6ater

60 6ater for 'n7ection

PS Pure steam

TDS Test Data Sheet

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• SOP for handling of the spillages in the laboratory

• SOP for cleaning procedure for >eblistering machine

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Regulator- :uidelines

'SO Kuidelines

6IO Kuidelines

LS.0>% Kuidelines

'CI Kuidelines

MI)%.L Kuidelines

MCC Kuidelines .South %frica

TK% Kuidelines.%ustralia

MC% Kuidelines.Nimbabwe

Schedule M.'ndia

Buropean Kuidelines

MB>S%0B Kuidelines .+ew/eland

KCC Kuidelines .Kulf

P>M% Kuidelines .apan

P%+>)I Kuidelines .%merican

P'C


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• SOP 3or HP%! nal-sis nd (ocumentation

• SOP 3or Identi)ication O) +icorganisms

• SOP 3or +aintenance O) (esiccator

• SOP 3or +onitoring O) Ra* nd Pota,le Water ?ualit-

• SOP 3or Operation nd !ali,ration O) 3T@IR Spectrometer

• SOP 3or Operation nd !ali,ration O) %ea4 Test pparatus

• SOP 3or Operation nd !ali,ration O) Tap (ensit- pparatus

• SOP 3or Operation nd !ali,ration O) Water $ath

• SOP 3or Operation nd !ali,ration o) uto Titrator ation

E))icienc-

• SOP 3or handling o) mar4et complaints

• SOP )or ntimicro,ial e))ecti7eness testing

• SOP )or !leaning and Operation o) naero,ic !ulture Aar

• SOP )or !leaning o) :lass*are

• SOP )or (eaeration o) (issolution media

• SOP )or (isposa,le o) media)ill 7ials a)ter incu,ation

• SOP )or Entr- and Eit procedure )or micro,iolog- testing area and Sterilit-

testing area• SOP )or Identi)ication o) micro,ial cultures using ,iomeriu identi)ication s-stem

• SOP )or %.O.(. o7en

• SOP )or +icro,ial staining procedures

• SOP )or +onitoring o) !ompressed ir/:ases )or +icro,iological; #on@2ia,le

Particulate; Oil and +oisture !ontent

• SOP )or Operation and !ali,ration o) !onducti7it- meter

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9/17

• SOP )or Operation and !ali,ration o) Top Pan $alance

• SOP )or Operation and !leaning o) !olon- !ounter

• SOP )or Operation and !leaning o) :arment !u,icle

• SOP )or Operation and !leaning o) Pass ,o

• SOP )or Operation and !leaning o) 2ertical Porta,le utocla7e

• SOP )or Operation and +aintenance o) Sterili>ation Reel Sealer

• SOP )or Operation and Per)ormance 6uali)ication o) $iomerieu Bit


10/17

• SOP )or cali,ration o) Polarimeter

• SOP )or cali,ration o) autotitrator

• SOP )or cali,ration o) ,alance

• SOP )or cali,ration o) conducti7it- T(S meter

• SOP )or cali,ration o) disintegration test apparatus

• SOP )or cali,ration o) hardness tester

• SOP )or cali,ration o) in)rared moisture ,alance

• SOP )or cali,ration o) 4arl )ischer apparatus

• SOP )or cali,ration o) plunger operated pipette

• SOP )or cali,ration o) re)ractometer

• SOP )or cali,ration o) the re)ractometer

• SOP )or cali,ration o) *al4@in@ incu,ators 0@Dc and "0@"Dc

• SOP )or cali,ration procedure o) u.7.ca,inet

• SOP )or care)ul handling o) poisonous chemicals

• SOP )or chec4 suita,ilit- o) dissolution test apparatus

• SOP )or cleaning and disin)ection

• SOP )or cleaning and operation o) R%3 unit in Sampling Room

• SOP )or cleaning and operation o) incu,ator

• SOP )or cleaning )or (HS

• SOP )or cleaning o) (ispensing Sampling Room

• SOP )or cleaning o) +etrohm Barl )isher

• SOP )or cleaning o) 2ertical utocla7e

• SOP )or cleaning o) automatic distillation apparatus

• SOP )or cleaning o) colon- counter

• SOP )or cleaning o) disintegration test apparatus

• SOP )or cleaning o) dissolution tester

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• SOP )or cleaning o) melting point apparatus

• SOP )or cleaning o) o7en )or incu,ator at Dc

• SOP )or cleaning o) slit to agar air sampler

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• SOP )or cleaning procedure )or $lister Pac4ing +achine

• SOP )or cleaning procedure )or !olloidal +ill

• SOP )or cleaning procedure )or (e,listering machine

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11/17

• SOP )or cleaning procedure )or (ehumidi)ier

• SOP )or cleaning procedure )or EP( !ollator machine *ith strip pac4ing machine

line

• SOP )or cleaning procedure )or 3$( $ag

• SOP )or cleaning procedure )or Hose Pipe O) (ust Etraction S-stem

• SOP )or cleaning procedure )or +ini roll compactor

• SOP )or cleaning procedure )or Paste Bettle

• SOP )or cleaning procedure )or Rapid +ier :ranulator one reader

• SOP )or cleaning procedure o) ,alances

• SOP )or cleaning procedure o) deep )ree>er

• SOP )or cleaning procedure o) puncture resistance tester

• SOP )or cleaning procedure o) sterile dress ca,inate

• SOP )or collection and storage o) retained samples o) pac4aging material

• SOP )or control o) master data generation ,- computer s-stem

• SOP )or destruction o) control samples


12/17

• SOP )or en7ironmental monitoring o) dispensing and sampling area in ra*

materials

• SOP )or en7ironmental monitoring o) solid dosage )orm area ,- non 7ia,le air

particle count

• SOP )or e7aluation o) en7ironmental monitoring results e o) ra* materials using microscopic

method

• SOP )or general test procedure

• SOP )or go*ning procedure )or the 7isitors

• SOP )or guideline )or storage condition o) ra* material

• SOP )or hand *ash procedure

• SOP )or handling and control )or the prohi,ited items

• SOP )or handling and testing o) 7arious samples

• SOP )or handling o) glass*are

• SOP )or handling o) spillage o) solid/li6uid media containing gro*th

• SOP )or heat distri,ution stud- in cham,er o) dep-rogemation o7en using

di))erent pro,e *ith data logger

• SOP )or heat distri,ution stud- in o7en using multi pro,e data logger

• SOP )or hplc column receipt chec4ing and regeneration

• SOP )or identi)ication o) organisms

• SOP )or in7entor- and issuances o) media in 6ualit- control la,

• SOP )or in7estigation o) sterilit- test )ailure

• SOP )or la,orator- sa)et-

• SOP )or laminar air )lo* *or4station

• SOP )or logic )or gi7ing num,er to the method )or anal-sis o) )inished product and

ra* material

• SOP )or maintenance cleaning procedure )or sampling e6uipment

• SOP )or maintenance o) desiccator

• SOP )or media disposal

• SOP )or method )or programme )ile chec4s o) so)t*are o) instruments

• SOP )or micro,ial limit test )or ra* materials and )inished products

• SOP )or micro,ial testing o) drain *ater

• SOP )or micro,iological monitoring o) clean e6uipment in to solid dosage area. F

s*a, method

• SOP )or mu))el )urnace

• SOP )or operating procedure o) (ehumidi)ier

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20target=http://www.whoguidelines.com/2011/07/sop-for-handling-of-spillages-in.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/07/sop-for-handling-of-spillages-in.html%22%22=%22%22%20target=http://www.whoguidelines.com/2012/01/sop-for-heat-distribution-study-in.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-heating-block-validation.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-identification-of-contaminant.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-instrument-for-macroscopical.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-investigation-for-out-of-action.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/07/sop-for-laboratory-cleaning.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-lal-test-by-gel-clot-method.html%22%22=%22%22%20target=http://www.whoguidelines.com/2008/05/sop-for-leak-test-of-strip-blister-and.html%22%22=%22%22%20target=http://www.whoguidelines.com/2008/05/sop-for-leak-test-of-strip-blister-and.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/08/sop-for-logic-for-giving-number-to.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/11/sop-for-maintenance-and-transfer-of.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/06/sop-for-manual-glassware-cleaning.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/11/sop-for-media-preparation.html%22%22=%22%22%20target=http://www.whoguidelines.com/2012/01/sop-for-metone-laser-particle-counter.html%22%22=%22%22%20target=http://www.whoguidelines.com/2012/01/sop-for-microbial-monitoring-of.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-microbiological-integrity.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-microbiological-integrity.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-microscope.html%22%22=%22%22%20target=http://www.whoguidelines.com/2011/12/sop-for-numbering-system-of-media.html%22%22=%22%22%20target=


13/17

• SOP )or operating procedure o) culture ca,inet

• SOP )or operating procedure o) dou,le door autocla7e

• SOP )or operating procedure o) laminar air )lo*

• SOP )or operation and cal,ration o) dr- ,ath

• SOP )or operation and cali,ration o) ,ursting strength tester

• SOP )or operation and cali,ration o) pH meter


14/17

• SOP )or procedure )or Operation o) 2i,ro Si)ter

• SOP )or procedure )or Ordering; Recei7ing; Storage; Issue; (estruction o) (ies

Punches

• SOP )or procedure )or Pre 3ilter cleaning o) R%3

• SOP )or procedure )or Receipt; Issuance; Storage and Handling o) sol7ent

• SOP )or procedure )or Ta,let granulation; compression and coating

• SOP )or procedure )or action to ,e ta4en during spillage/,rea4age o) materials

• SOP )or procedure )or anal-st 7alidation

• SOP )or procedure )or cali,ration o) instruments

• SOP )or procedure )or carr-ing out air ,orne particle count in static condition

• SOP )or procedure )or cleaning and maintenance o) ,oilers

• SOP )or procedure )or cleaning installation; operational and per)ormance

6uali)ication o) e6uipment / instruments.• SOP )or procedure )or cleaning o) ,arrel pump pipe

• SOP )or procedure )or cleaning o) clean area

• SOP )or procedure )or cleaning o) e6uipment and accessories in Production rea

• SOP )or procedure )or cleaning o) micro,iological glass*are

• SOP )or procedure )or collection and storage o) control sample

• SOP )or procedure )or cooling to*ers

• SOP )or procedure )or destruction o) reCected materials

• SOP )or procedure )or electrical sa)et-

• SOP )or procedure )or entering in sterilit- testing room

• SOP )or procedure )or en7ironmental monitoring o) aspetic area5 )inger prints and

go*n sampling

• SOP )or procedure )or en7ironmental monitoring o) parenteral processing area 5

sur)ace testing ,- means o) rodac plate and s*a,

• SOP )or procedure )or )umigation in micro,iolog- la,

• SOP )or procedure )or handling o) ReCected Ra* +aterial

• SOP )or procedure )or handling o) sie7es and screen

• SOP )or procedure )or inspection o) pressure 7essels; li)ts and chain pulle- ,loc4s

• SOP )or procedure )or issuance o) additional pac4aging materials

• SOP )or procedure )or maintaining and up@4eeping the )acilit-

• SOP )or procedure )or ma4ing production related entries in SP s-stem

• SOP )or procedure )or measurement o) air 7elocit- and calculation o) air changes

per hour )or classi)ied areas

• SOP )or procedure )or operating and cleaning o) 2acuum !leaner

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15/17

• SOP )or procedure )or operation a)ter +.S.E.$. po*er )ailure

• SOP )or procedure )or operation and cali,ration o) precision o7en

• SOP )or procedure )or operation and maintenance o) lo* tension


16/17

• SOP )or procedure )or the operation o) Semi@utomatic !artoning +achine


17/17

• WHO SOP list )or Pharma ?ualit- ssurance

• WHO SOP list )or Pharma ?ualit- !ontrol !leaning

• Water sampling procedure

•

•

• !op-right 00J@01 ***.*hoguidelines.com. Po*ered ,- $logger.
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pharmaceutical cgmp guidelines water sampling procedure

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