Module 3 Presentations

07/05/2024

What is Good Manufacturing Practice?

• EMA Definition: Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. • Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP. • GMP requires that medicines: • are of consistent high quality • are appropriate for their intended use • meet the requirements of the marketing authorisation or clinical trial authorisation.

The Organisation for Professionals in Regulatory Affairs

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Basic Medicinal Products GMP Requirements

• Pharmaceutical Quality System • Personnel • Premises and Equipment • Documentation • Production • Quality Control • Outsourced Activities • Complaints and Product Recall • Self Inspection

The Organisation for Professionals in Regulatory Affairs

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