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Glossary

Qualified Person (QP)

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It is a legal requirement for every manufacturer of pharmaceutical products to have a Qualified Person. 

Assuring the quality of medicines requires a thorough understanding of pharmaceutical law and administration, Pharmaceutical Quality Systems (PQS) and Good Manufacturing Practice (GMP). Pharmaceutical manufacturing supply chains are global and an increasingly complex landscape which the QP must be able to skilfully navigate to uphold patient safety. 

Other glossary definitions

A

Acceptance Criteria

Numerical limits, ranges, or other suitable measures for acceptance of the results of analytical procedures…

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C

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA,…

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