Active good manufacturing practice

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients... 

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). 

Annex 18 Good manufacturing practice for active pharmaceutical ingredients (The ICH Guide) Annex 19 Reference and Retention Samples... 

Medicinal products and bulk pharmaceutical chemicals are produced mainly in batch processes. Controlling these products and chemicals at the end of their manufacturing processes is not in line with the general principle of quality assurance, which is that quality should be built into the product. It is then necessary to ensure that appropriate good manufacturing practices are adhered to throughout the manufacture of both bulk pharmaceutical chemicals (active ingredients as well as excipients) and medicinal products. 

Good Manufacturing Practice for Active Ingredient Manufacturers , 1996, CEFIC-EFPIA, August. 

Tab. 14.1 The role ofGMP (good manufacturing practice) in the production and processing of APIs (active pharmaceutical ingredients) from difference sources. It is not yet clear how biotechnology-derived plants fit into this scheme. Modified from the Good Manufacturing Practice Guide for Active Pharmacuetical Ingreedients, ICH (2000).

Source Adapted from International Conference for Harmonization. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, ICH Q7,2000. 

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. 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, 2000. 

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. 

Ensure that all medicines manufacturing, importation, exportation, wholesale and distribution establishments are licensed. Activities and premises must comply with Good Manufacturing Practices (GMP) and Good Distribution Practice requirements... 

ICH Q7A, Good Manufacturing Practice for Active Pharmaceutical Ingredients. http //WWW. f d a. go V... 

Action of proving, in accordance with the principles of good manufacturing practice, that any procedure, process, equipment, material, activity, or system actually leads to the expected result Documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes and characteristics... 

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