Active pharmaceutical ingredient Good Manufacturing Practice

Pharmaceutical Inspection Convention. Internationally Harmonized Guide for Active Pharmaceutical Ingredients—Good Manufacturing Practice. September 1997. 

Anonymous (1992), Annex 1 Good manufacturing practices for pharmaceutical products Good manufacturing practices for active pharmaceutical ingredients (bulk drug... 

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

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. 

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. 

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

U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (2001, Aug.), Guidance for industry Q7A good manufacturing practice guidance for active pharmaceutical Ingredients, DHHS, Rockville, MD. 

International Conference on Harmonization (ICH) (2000), Good manufacturing practice guide for active pharmaceutical ingredients, ICH, Geneva. 

Recendy the CTD (the Common Technical Dossier) and its electronic format (the eCTD) have caught most of the attention. The ICH has also moved into the GMP arena as well, with the development of the global Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients [23],... 

Myres, G. J., The Art of Software Testing, New York Wiley, 1979 ICH. Harmonized tripartite guideline. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. ICH Steering Committee. Nov. 10,2000. 

Q7A cal/Biological Products Good Manufacturing Practices for Active Pharmaceutical Ingredients CPMP/ICH/4011/00 Step 5... 

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