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Good manufacturing practices guide

Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients... [Pg.60]

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). 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. [Pg.288]

International Conference on Harmonization (ICH) (2000), Good manufacturing practice guide for active pharmaceutical ingredients, ICH, Geneva. [Pg.838]

The IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001. [Pg.388]

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],... [Pg.864]

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. [Pg.250]

Mervcill, A. A good manufacturing practices guide for bulk pharmaceutical excipients. Pharm. Technol. (USA) 1995, 19, 34 0. [Pg.1621]


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