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GMP News

Microbiological Contamination Control of Non-Sterile Medicinal Products – EMA Q&A

Contamination control measures also play an important role in the case of non-sterile medicines. A new Q&A from the EMA answers questions on this topic.

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Pre-approval Inspections: FDA introduces New Guidance

The FDA is currently revising its guidance on pre-approval inspections (PAI). The amendments mainly concern the introduction of a risk-based approach to inspection planning and the use of alternative methods.

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Do you know about QPSHARE?

The European QP Association (EQPA) is committed to providing practical tools for Qualified Persons (QPs) to support them in their day-to-day responsibilities. One such tool is QPSHARE, which all members can access free of charge to foster audit collaboration.

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