Finished products Good Manufacturing Practice

Good Manufacturing Practice. The GMPs were issued by the U.S. FDA in 1978 to provide minimum quahty standards in the production of pharmaceuticals (qv) for the finished dosage form as well as their ingredients. The standard has been updated periodically. 

Production Facilities. The manufacture of acceptable cosmetic products requires not only safe ingredients but also faciUties that maintain high standards of quaUty and cleanliness. Most countries have estabUshed regulations intended to assure that no substandard product or batch is distributed to consumers. Good Manufacturing Practices (GMP) represent workable standards that cover every aspect of dmg manufacture, from building constmction to distribution of finished products. GMPs in the United States that have been estabUshed for dmg manufacture are commonly used in cosmetic production (6,25). 

Current Good Manufacturing Practice for Finished Pharmaceuticals, Sampling and Testing of In-Process Materials and Drug Products, (1998), CFR, Title 21, Part 211, Volume 4, Section 211.110. 

Analytical methods and specifications must be established and validated so as to define and control the quality and purity of the raw materials, intermediates and the finished product. For many standard chemical raw materials, the development of specifications will not be necessary as they are already published in US and European pharmacopoeia (for example, standards for water, organic solvents and various excipients). The ultimate objective of these activities is to be able to manufacture the drugs required for clinical trials in accordance with good manufacturing practice (GMP). 

All stages of antibiotic manufacture from fermentation through to finished product are governed by the code of good manufacturing practice (GMP), of whieh quality eontrol is one aspect. GMP requires that there should be a eomprehensive system, so designed, documented, implemented and controlled, and so furnished with personnel, equipment and other resourees as to provide assuranee that products will consistently be of a quality appropriate to their intended use. ... 

Parts 210 and 211 of CFR Title 21 are the laws defining good manufacturing practices for finished pharmaceutical products. All manufacturers must follow these regulations in order to market their products in the United States. When a firm files an application to market a product in the United States through a New Drug Application (NDA), abbreviated NDA, (ANDA), Biological License Application (BLA),... 

FDA, Current Good Manufacturing Practices for Finished Pharmaceutical Products 21 CFR 211.25(a). European Union Food Manufacturing Practice for Pharmaceuticals, Medicines Controls Agency, 1997. David Begg Associates (2002), Computers and Automated Systems Quality and Compliance, June,... 

Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21 CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. 

A person (among key personnel of a manufacturing establishment) responsible for the release of batches of finished products for sale. In some good manufacturing practice (GMP) guides and legal texts, the term qualified person is used to describe analogous functions. 

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