Guidelines for good manufacturing

Council of Europe, 93SPT28E.CO, Guidelines for Good Manufacturing Practice in the Cosmetics Industry. 

Source CCIC, Guidelines for good manufacturing practices Use of certified FD C colors in food. Certified Color Industry Committee, FoodTechnol., 22(8), 14,1968. 

Volume 4 - Guidelines for good manufacturing practices for medicinal products for human and veterinary use (see Sect. 35.5.7)... 

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). 

The major regulatory guidelines for Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) are similarly vague. Fitness for purpose is the phrase that is commonly used, but what does this mean in practice ... 

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. 

Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products. 

ICH Guideline Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, www.ich.org. 

One of the alternative approaches under the 510(k) paradigm is Special 510(k) Device Modifications. This approach utilizes certain aspects of the Quality System Regulations (Quality System Requirements for Good Manufacturing Practices). The other alternative is the Abbreviated 510(k). This approach utilizes special controls in which standards or voluntary guidelines can facilitate 510(k) review and expedite evaluation. 

Anon. Good Manufacturing Practices Supplementary Guidelines for the Manufacture of Herbal Medicinal Products. WHO Technical Report Series No. 863. Geneva, Switzerland World Health Organization, 1996 109-113. 

Anonymous (2002), Annex 3 Guidelines on good manufacturing practices for radiopharmaceutical products, in WHO Expert Committee on Specifications for Pharmaceutical Preparations 37th Report, WHO Technical Report Series 908, World Health Organization, Singapore, pp. 26-35, available http //whqlibdoc.who.int/trs/WHO TRS 908.pdf. 

World Health Organization (WHO) (2006), WHO expert committee on specifications for pharmaceutical preparations (fortieth report)—Supplementary guidelines on good manufacturing practices (GMP) Validation, WHO, Geneva. 

ICH Guidelines, Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical... 

Good manufacturing practices for pharmaceutical products supplementary guidelines for the manufacture of investigational pharmaceutical products for studies in humans, 1994. http // satum.who.ch/uhtbin/cgisirsi/... 

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