Guide to Good Pharmaceutical Manufacturing Practice
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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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