Sterilization, Good Manufacturing Practice

Underwood E. (1998) Good manufacturing practice. In Principles and Practice of Disinfection, Preservation and Sterilization (eds A.D. Russell, W.B. Hugo G. AJ. Ayliffe), 3rd edn. Oxford Blackwell Scientific Publications. 

The Rules Governing Medicinal Products in the European Union, Vol. 4, Good Manufacturing Practices— Medicinal Products for Human and Vetrinary Use, Annex I Manufacture of Sterile Medicinal Products, Commission Directive 91/356/EEC of 13 June 1991. 

Sterile Drug Produets Produeed by Aseptie Proeessing Current Good Manufacturing Practices... 

Finally, radiopharmaceuticals are often prepared on a daily basis within the framework of clinical studies which often last several months or years. They demand a viable and reproducible production chain, leading to a sterile- and pyrogen-free radiopharmaceutical of high radiochemical purity. Therefore, microprocessor-controlled automated synthesis devices [31] are developed in order to ensure routine pharmaceutical production. They are becoming mandatory in order to meet the demands related to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). 

Record keeping is a prime requirement of current good manufacturing practices. The records required for a validated steam sterilization cycle are listed below ... 

Anonymous (2002), Annex 6 Good manufacturing practices for sterile pharmaceutical products, in WHO Expert Committee on Specifications for Pharmaceutical Preparations 36th Report, WHO Technical Report Series 902, World Health Organization, Singapore, pp. 76-93, available http //whqhbdoc.who.int/trs/WHO TRS 902.pdf. 

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. 

EC (2003), Guide to Good Manufacturing Practice Manufacture of Sterile Medicinal Products, Revision to Annex 1, Brussels. Available at http //europa.eu.int/comm/ enterprise/pharmaceuticals/eudralex/vol-4/pdfs-en/revanl vol4 3.pdf (accessed October 2006). 

WHO (2002), Good manufacturing practices for sterile pharmaceutical products, Geneva, pp. 76-96 [Technical Report Series, no. 902]. 

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. 

European Union Guide to Good Manufacturing Practice Annex 1 on the Manufacture of Sterile Medicinal Products European Commission, 1996.. 

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