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GUIDE TO GOOD MANUFACTURING PRACTICE FOR …
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.
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009-8 (Annexes) 15 January 2009 PE 009-8 (Annexes) 15 January 2009
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