Transcription of GUIDE TO GOOD MANUFACTURING PRACTICE …
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GUIDE TO GOOD MANUFACTURING PRACTICE …
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009 8 (Annexes) 15 January 2009 PE 009 8 (Annexes) 15 January 2009 GUIDE TO good MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES PIC/S January 2009 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat 14 rue du Roveray CH 1207 Geneva e mail: web site: Table of contents PE 009 8 (Annexes) i 15 January 2009 ANNEXES Annex 1 Manufacture of sterile medicinal 1 1 1 Clean room and clean air device 2 Clean room and clean air device monitoring .. 3 Isolator 5 Blow/fill/seal 6 Terminally sterilised 6 Aseptic 7 Personnel .. 7 Premises .. 8 Equipment .. 10 Sanitation .. 10 10 13 Sterilisation by heat .. 13 Moist 14 Dry 14 Sterilisation by 14 Sterilisation with ethylene 15 Filtration of medicinal products which cannot be sterilised in their final container.
Table of contents PE 009-8 (Annexes) -i-15 January 2009 ANNEXES Annex 1 Manufacture of sterile medicinal products.....1
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