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GMP News

Root Cause Analysis and CAPA: Two more Warning Letters issued to Companies in Europe

Almost every week, the US FDA publishes Warning Letters in which it criticises companies for inadequate CAPA measures and insufficient Quality Oversight. Now two sites in the EU have been affected

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GMP for Active Substances - What are the fundamental Requirements of the ICH Q7 Guideline? - Part 2

Part 2: For manufacturers of active substances, compliance with GMP rules according to ICH Q7 is the key benchmark for the appropriate manufacture of active pharmaceutical ingredients. The requirements are aimed at ensuring that the active substance is manufactured, tested, stored and supplied in the required quality and purity.

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The Relationship between Commissioning, Classification and Qualification in GMP Cleanrooms

When setting up a new cleanroom for pharmaceutical/GMP production, three terms are often confused: commissioning, classification and qualification. In practice, these steps are closely interlinked. However, from a regulatory and technical perspective, they have different functions.

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