Good practice, pharmaceutical manufacture

WHO GMP. Good Practices in Manufacturing of Pharmaceutical Products in WHO Expert Committee on Specifications for Pharmaceutical Preparations, 32 edition, Geneva (1992). 

Packaging, storage and transport 4 Guide to Good Pharmaceutical Manufacturing Practice... 

Chemical and pharmaceutical manufacturers must establish their own internal reference materials, when no pharmacopoeial monograph exists, to satisfy the requirements of Good Manufacturing Practice (European Commission 1997). 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

In pharmaceutical manufacturing, process validation is an exercise that requires the contribution from different departments, including quality assurance and quality control. It is a requirement for good manufacturing practice (GMP) to ensure that the final product produced is of the expected quality. 

In an open-book situation, expect a number of proprietary (trade) names or diseases. Although candidates are allowed to look up all the trade names in the textbooks available, in an examination this is not practical and sometimes impossible to achieve in the allocated time. Check the active ingredients of a proprietary name only when necessary or when in doubt. You are expected to have a good knowledge of most brands and pharmaceutical manufacturers (Q26-40). 

Adequate documentation forms an essential part of good manufacturing practice. For this reason, every aspect of pharmaceutical manufacture is characterized by the existence of extensive associated documentation. This is essential in order to ... 

International Society for Pharmaceutical Engineering (ISPE) (2002), GAMP (Good Automated Manufacturing Practice) Guide for Validation of Automated System in Pharmaceutical Manufacturing, Version 4, ISPE. 

Rules and Guidance for Pharmaceutical Manufacturers and Distributors, part 4, Guide to Good Manufacturing Practice for Medical Products, Chapter 6.7, Documentation, 1997. 

User requirement specifications cover more aspects than only the GMP requirement, because the URS is not written only for the validation procedure in fact, a URS is a very important project document covering technical as well as economic requirements of the technical system. Pharmaceutical manufacturing departments not only check the GMP aspects of a system additionally, following good engineering practice they will review the technical and economic aspects of a technical system. Obviously, the more experience a company gains, the more comprehensive a URS become. Past experiences such as project faults, inefficient technical systems, and bad commissioning can be included in a URS. 

Good manufacturing practice regulations identify what controls must be in place and adhered to in order to be in compliance, but do not provide instruction on how to implement these controls. The methods used to ensure the product meets its defined requirements are the responsibility of the pharmaceutical manufacturer, who must be prepared to demonstrate GMP compliance with validated systems and formal records. 

Medicines Control Agency (MCA). Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997, Part Four—Good Manufacturing Practice for Medicinal Products. The Stationary Office, London. 

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