Good Manufacturing Practice: Frequently asked questions

 

The frequently asked questions section contains previous questions discussed at symposia, Good Manufacturing Practice (GMP) Consultative Committee meetings and others received by the GMP Inspectorate. Some questions relate to specific circumstances as submitted, but where possible the questions have been answered in a general vein. The Q&As should therefore be considered carefully in relation to individual circumstances and any specific concerns should be discussed with a GMP/GDP inspector. Additional Q&As are also available for reference by following the related link to the European Medicines Agency (EMA) website.

Investigational medicinal products (IMP) FAQs

This page provides answers to frequently asked questions regarding investigational medicinal products (IMP).
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Importation FAQs

This page provides answers to frequently asked questions regarding importation of medicines.
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General FAQs

This page provides answers to general GMP frequently asked questions.
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Out of specification (OOS) FAQs

These FAQs and interactive presentation provide guidance on what to do if an out of specification result is identified during laboratory analysis.
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Related links

Clinical trials for medicinal products
The Medicines for Human Use (Clinical Trials) Regulations 2004: SI 2004/1031 (external link)
The Medicines for Human Use (Manufacturing, Wholesale Dealing and
Miscellaneous Amendments) Regulations 2005 - SI 2005/2789 (external link)
The Medicines for Human Use (marketing authorisations etc.)
Regulations 1994 - SI 1994/3144 (external link)
Royal Pharmaceutical Society of Great Britain (external link)
EMA: Good Manufacturing Practice - Questions and answers (external link)
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Active pharmaceutical ingredient (API) FAQs

This page provides answers to frequently asked questions regarding active pharmaceutical ingredients (APIs).

Pharmacovigilance FAQs

This page provides answers to frequently asked questions regarding pharmacovigilance.

Common deficiencies

This page provides some common inspection findings and current areas of concern that have been identified during recent inspections.

Quality risk management

This page provides answers to frequently asked questions about quality risk management.
Page last modified: 29 November 2010