Maintenance Annex Guidance
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Annex 2 W HO good manufacturing practices for active ...
www.who.int18. Specifi c guidance for APIs manufactured by cell culture/fermentation 18.1 General 18.2 Cell bank maintenance and record keeping 18.3 Cell culture/fermentation 18.4 Harvesting, isolation and purifi cation 18.5 Viral removal/inactivation steps 19. APIs for use in clinical trials 19.1 General 19.2 Quality 19.3 Equipment and facilities
INTERNATIONAL ISO STANDARD 14224 - Maintenance
www.maintenance.orgcorrective maintenance maintenance carried out after fault recognition and intended to put an item into a state in which it can perform a required function [IEC 60050-191:1990] NOTE For more specific information, refer to Figure 191-10 "Maintenance time diagram" in …
Annex 5 Guidelines for stability testing of pharmaceutical ...
www.paho.orgAnnex 5 Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms ... should guarantee the maintenance of quality, safety, and efficacy th roughout the shelf-life of a product. The effect on products of the extremely adverse climatic conditions