Guide to Good Manufacturing Practice , GMP

Chaloner-Larsson, G, Anderson, R., and Egan, A. A WHO Guide to Good Manufacturing Practice (GMP) Requirements, 1997, World Health Organization, Geneva. 

Good documentation constitutes an essential part of the quality assurance system. As claimed in the European Community (EC) Guide to Good Manufacturing Practice (GMP), Chapter 4 Clearly written documentation prevents errors from spoken communications and permits tracing of batch history. In general, the requirements for documentation related to manufacturing of pharmaceuticals, as set in the GMP... 

A more recent OECD consensus paper [5] requires the development of software in a quality system environment There should be adequate documentation that each system was developed in a controlled manner and preferably to recognized quality and technical standards (e.g. ISO 9001) Similarly the European Union requires in Annex 11 of the EC guide to good manufacturing practice (GMP) for medicinal products [6] The user shall ensure that software has been produced in accordance with a system of quality assurance . 

Manufacturing sites within Australia must comply with the Australian Code of GMP for Medicinal Products - August 2002, which is based entirely on the international standard Guide to Good Manufacturing Practices for Medicinal Products, Version PHl/97 (Rev.3) 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The ICH GMP Guide for Active Pharmaceutical Ingredients has also been adopted. 

The use of computerized systems in the GMP environment in Europe is mainly driven by Annex 11 to the Guide to Good Manufacturing Practices. As Annex 11... 

Guide to Good Manufacturing Practice for Medicinal Products, The GMP Directives 91/356/EEC and 91/341/EEC (1991), European Commission... 

European Commission. 1998. EC GMP guide to good manufacturing practice. Revised Annex 1 Manufacture of sterile medicinal products. In The rules governing medicinal products in the EU. Vol. 4 Good Manufacturing Practices. Luxembourg European Commission. 

European Free Trade Agreement (1992) Guide to good manufacturing practice for pharmaceutical products, the convention for the mutual recognition of inspections in respect of the manufacture of pharmaceutical products. Document 5/92 (PIC guidelines on GMP). European Free... 

PE 009-10 Guide to good manufacturing practice for medicinal products - Part I (2013) — Part II (2013) — Annexes (2013). The content of this guide resembles, more or less, European GMP, except for a few definitions. 

CDER web site http //www.fda.gov/cder. A complete section is dedicated to the Internationally Harmonised Guide for Active Pharmaceutical Ingredients (API) and Good Manufacturing Practice (GMP), Washington, Sept. 1997. 

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. 

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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