Good Manufacturing Practice Harmonization

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

International Conference on Harmonization (ICH) (2001), Guidance for industry. Q7A good manufacturing practice guidance for active pharmaceutical ingredients, ICH, Brussels, Belgium. 

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. 

International Organization on Harmonisation (2000), ICH harmonized tripartite guideline Good manufacturing practice guide for active pharmaceutical ingredients, available http //www.ICH.org, accessed June 23,2005. 

Good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice (GLP) guidelines of the EU were issued uid the drug approval application format Wcis harmonized with the EU Notice for Applicants. 

Important protocols for method validation in the literature have been derived, amongst others, from the Current Good Manufacturing Practice, Code of Federal Regulations, Food and Drug Administration, National Drug Administration, the United States Pharmacopoeia Convention, the American Public Health Association and the International Conference on Harmonization. 

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

The World Health Organization (WHO) has guidelines for good manufacturing practices (GMP), published as Technical Reports. Many countries have formulated their own requirements for GMP based on the WHO GMP or they have harmonized their requirements, for example in the European Union (EU-GMP). 

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