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Glossary

Good Manufacturing Requirements (GMP)

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Good Manufacturing Practice. This is a recognised standard for pharmaceutical processing and manufacture ensuring medicinal products are consistently produced and controlled 

Other glossary definitions

P

Pre-Market Notification (510(k))

The US Food and Drug Administration (FDA) requires a 510(k) for moderate-risk Class II medical…

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C

Comparability Protocol

A comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change…

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