Pharmaceutical Water Systems

Alain Kupferman

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors Nan in!" Novem#er $%%&

FA'()*S ')N(*+,-(+NG () .-A/+(0 P*)D-'(S

Personnel 1alidated processes Water for Pharmaceutical -se PW 4PW WF+ 'S Packin! Materials 2nvironment Premises Procedures

*aw Materials 23uipment

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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P*2*2.-+S+(2S F)* )P2*A(+)N AND 5*26.-A/+F+'A(+)N

As usual Good design Good engineering Good execution Good operation Good documentation and Good maintenance

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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D2F+N+NG (42 N22DS

Regulatory (Pharmacopeia)
PW HPW W ! "# $ P!%& $ 'A $

#ser re(uirements 'ata on ra) )ater

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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D2F+N+NG (42 N22DS7 W4+'4 (0P2 )F WA(2* W42*2 8

Regulatory (Pharmacopeia)
PW HPW W !
"# $ P!%& $ 'A $

Regulatory ("*"A)

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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D2F+N+NG (42 N22DS7 W4+'4 (0P2 )F WA(2* W42*2 8

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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GMP 9 G2P

'raina+ility , slopes lo) speed !n-process controls. sampling points /al0es and accessories &i1e of generator(s) and storage tan2s %ritical parameters handling "tc3

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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-S2* *2.-+*2M2N(S

4uantitati0e data, !nstallation type, 6oop type and storage, &anitisation, *aterials, Heat exchangers,

ho) much )hen $ !". R5. dou+le R5. "'! *ulti-effect. thermocompression.33 hot. cold. mixed. multiple fixed or 0aria+le speed pump deadlegs. 0al0e types. heat. chemical. o1one stainless steel $ 7 treatment type

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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.-A/+F+'A(+)N +(2MS
'ritical parameters handlin!

+'*A
+ ' * A : : : : +ndicate 'ontrol *ecord Alarm

,ase for instrumentation 3ualification

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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.-A/+F+'A(+)N +(2MS +.
!nspection of mechanical installation and documentation
(manuals. data sheets. components certificates)

&ystem installed in accordance )ith P8! diagram %hec2 of components (agree )ith description in components list) Gap +et)een )aste )ater and drain 'ead legs in distri+ution system (9'. :'. ;.< ' $$$)
FDA not havin! an unused portion !reater in len!th than si; diameters of the unused pipe measured from the a;is of the pipe in use

W4) Deadle!s in the pipework installation !reater than <"= times the #ranch diameter should #e avoided

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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GMP 9 G2P 'A/'-/A(+)N

Si>e of !enerator5s6 and stora!e tanks

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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.-A/+F+'A(+)N +(2MS +.
Welding documentation
(material certificates for pipes and fittings. 'A certificates for gas2ets) !sometric dra)ings )ith )eld num+ers Welded seam documentation (machine protocols) Welder appro0al test certificate Pic2ling and passi0ation protocol "ndoscopic photos Analytical certificate of inert gas

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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.-A/+F+'A(+)N +(2MS ).
%ali+ration of measuring e(uipment (Pressure. temperature. conducti0ity) 6ea2 test 5peration of softener (residual hardness. regeneration) 5peration of R5 plant (flo) rates. conducti0ity) 5peration of +isulphite dosing (if re(uired) unction of regulating circuits in R5 plant 5peration of o1one generator and o1one meter (o1one concentration) 5peration of #/ unit (51one concentration. intensity of light) &ystem parameters and limit-0alue settings lo) rate (Reynolds 0alue) Water (uality (conducti0ity. micro+iological situation. =5%)

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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.-A/+F+'A(+)N +(2MS ).
Gradients in distri+ution system 'raina+ility of distri+ution system !nspection of electrical hard)are "mergency-off s)itch Analogue inputs and outputs Program steps disinfection softener. R5 Program steps sanitisation softener. R5. "'!. loop Alarms Access rights. pass)ords

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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P2*F)*MAN'2 .-A/+F+'A(+)N
:-phased approach
Phase + (>-? )ee2s)

Water is not used for production purposes

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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P2*F)*MAN'2 .-A/+F+'A(+)N
:-phased approach
Phase ++ (>-? )ee2s)
Same samplin! scheme as phase +

Water can #e used for production purposes

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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P2*F)*MAN'2 .-A/+F+'A(+)N
:-phased approach
Phase +++ (<@ )ee2s)

Water can #e used for production purposes

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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S-,S2.-2N( P2*+)DS

%ontinuous system monitoring *aintenance (pre0entati0e) &ystem re0ie)s trending. performance. changes failures. in0estigations. 55&. etc3

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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?@ 8.uestions" please

, Manufacture of sterile medicines Advanced workshop for SFDA GMP inspectors

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