Guide to Good Pharmaceutical Manufacturing Practice

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Chapter: Pharmaceutical Microbiology : Principles Of Good Manufacturing Practice

The principles of this national guide were subsequently assimilated into the EC Guide to Good Manufacturing Practice for Medicinal Products in 1989 and are now published as Rules and Guidance for Pharmaceutical Manufacturers and Distributors (2007) by the MHRA.


GUIDE  TO  GOOD PHARMACEUTICAL MANUFACTURING  PRACTICE

 

Between 1971 and 1983 the essential features of GMP were covered in the UK by three editions of the Guide to Good Pharmaceutical Manufacturing Practice, frequently referred to as the ‘Orange Guide.’ This guide was prepared by the UK Medicines Inspectorate in consultation with industrial, hospital, professional and other interested parties. The principles of this national guide were subsequently assimilated into the EC Guide to Good Manufacturing Practice for Medicinal Products in 1989 and are now published as Rules and Guidance for Pharmaceutical Manufacturers and Distributors (2007) by the MHRA. The FDA has published FDA Requirements for cGMP Compliance (2007). Two important publications from the Pharmaceutical Press are Quality in the Manufacture of Medicines and Other Health Care Products (Sharp, 2000) and Quality Assurance of Aseptic Preparation Services (Beaney, 2005), which discusses manufacturing in hospitals.

 

Compliance with GMP is one of the major factors considered by the licensing authority when examining an application for a licence to manufacture under the Medicines Act (1968). Similar codes exist in the USA and other countries.

 

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