Good Manufacturing Practice sterilization processes

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2004, Sept.), Guidance for industry Sterile drug products produced by aseptic processing—Current good manufacturing practice, DHHS, Rockville, MD. 

The Good Manufacturing Practice (GMP) regulations, FDA, and European Economic Community (EEC) guidelines on aseptic processing, and other documents provide comprehensive details on facility requirements for sterile drag production. The facility must... 

FDA. FDA s proposed current good manufacturing practices (GMP) for regs. for large volume parenterals (LVP). Fed Reg (June 1, 1976). Preliminary Concept Paper of Sterile Drug Products Produced by Aseptic Processing, draft paper, Sept. 27, 2002. 

Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation and Cleaning Validation. This document is the basis for Annex 15 to the EC Guide on Good Manufacturing Practices for Medical Products. Figure 4 displays the most commonly used topics to be described in a VMP. 

PIC (1989) Guide to Good Manufacturing Practices of Pharmaceutical Products, PIC-Doc PH 5/89 (now PH 1/97 (rev. 2) [7]) Validation of critical processes, significant amendments to manufacturing processes, significant amendments to manufacturing processes, and of all sterilization processes and test methods stipulated. 

EU Guide to Good Manufacturing Practice, Draft revised version of Annexl5 Vahdation master plan Design qualification, instaUation and operational quahfication, non-sterile process vahdation, cleaning vahdation. 

Draft Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice. Food and Drug Administration Rockville MD, 2004. 

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