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Pe009 9 gmp guide Annexes

Pe009 9 gmp guide Annexes

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PHARMACEUTICAL INSPECTION CONVENTIONPHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 009-9 (Annexes) 1 September 2009
PE 009-9 (Annexes)1 September 2009
GUIDE TO GOOD MANUFACTURINGPRACTICE FOR MEDICINAL PRODUCTSANNEXES
© PIC/S September 2009Reproduction prohibited for commercial purposes.Reproduction for internal use is authorised,provided that the source is acknowledged.Editor: PIC/S Secretariat14 rue du RoverayCH-1207 Genevae-mail:
 
info@picscheme.orgweb site:http://www.picscheme.org 
 
Table of contents
PE 009-9 (Annexes) 1 September 2009
ANNEXES
Annex 1 Manufacture of sterile medicinal products...................................................1
 
Principle...............................................................................................................1
 
General................................................................................................................1Clean room and clean air device classification.....................................................2Clean room and clean air device monitoring........................................................3Isolator technology...............................................................................................5
 
Blow/fill/seal technology.......................................................................................6
 
Terminally sterilised products...............................................................................6
 
Aseptic preparation..............................................................................................7
 
Personnel............................................................................................................7
 
Premises.............................................................................................................8
 
Equipment.........................................................................................................10
 
Sanitation..........................................................................................................10
 
Processing.........................................................................................................10
 
Sterilisation........................................................................................................13
 
Sterilisation by heat...........................................................................................13
 
Moist heat..........................................................................................................14
 
Dry heat.............................................................................................................14
 
Sterilisation by radiation.....................................................................................14
 
Sterilisation with ethylene oxide.........................................................................15
 
Filtration of medicinal products which cannot be sterilised intheir final container............................................................................................16
 
Finishing of sterile products...............................................................................16
 
Quality Control...................................................................................................17
 
Annex 2 Manufacture of biological medicinal products for human use....................19
 
Scope................................................................................................................19
 
Principle.............................................................................................................19
 
Personnel..........................................................................................................20
 
Premises and Equipment...................................................................................21
 
Animal quarters and care...................................................................................22
 
Documentation..................................................................................................22
 
Production.........................................................................................................23
 
Starting materials......................................................................................23
 
Seed lot and cell bank system..................................................................23
 
Operating principles..................................................................................24
 
Quality control....................................................................................................24
 
Annex 3 Manufacture of radiopharmaceuticals.......................................................25
 
Principle.............................................................................................................25Introduction........................................................................................................25Quality Assurance..............................................................................................26Personnel..........................................................................................................27
 
Premises and equipment...................................................................................27
 
Table of contents
PE 009-9 (Annexes) -ii- 1 September 2009
Documentation..................................................................................................29Production.........................................................................................................29
 
Quality control....................................................................................................30
 
Reference and retention samples......................................................................31Distribution.........................................................................................................31Glossary............................................................................................................31Annex 4 Manufacture of veterinary medicinal products other thanimmunologicals.........................................................................................32Manufacture of premixed for medicated feeding stuffs.......................................32The manufacture of ectoparasiticides................................................................33The manufacture of veterinary medicinal products containing penicillins...........33Retention of samples.........................................................................................33Sterile veterinary medicinal products.................................................................33Annex 5 Manufacture of immunological veterinary medical products......................33Principle.............................................................................................................34Personnel..........................................................................................................34Premises...........................................................................................................35Equipment.........................................................................................................38Animals and animal houses...............................................................................39Disinfection waste disposal.............................................................................39Production.........................................................................................................40Starting materials...............................................................................................40Quality control....................................................................................................43Annex 6 Manufacture of medicinal gases...............................................................44
 
Principle.............................................................................................................44
 
Personnel..........................................................................................................44
 
Premises and equipment...................................................................................44
 
Documentation..................................................................................................45
 
Production.........................................................................................................46
 
Quality control....................................................................................................49
 
Storage and release..........................................................................................50
 
Glossary............................................................................................................50
 
Annex 7 Manufacture of herbal medicinal products................................................53
 
Principle.............................................................................................................53
 
Premises...........................................................................................................53
 
Storage areas...........................................................................................53
 
Production area........................................................................................53
 
Documentation..................................................................................................53
 
Specifications for starting materials..........................................................53
 
Processing instructions.............................................................................54
 
Sampling...........................................................................................................54
 
Quality Control...................................................................................................55
 

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