Tag: Annex 15

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EU GMP Annex 15 revision concept paper highlights showing pharmaceutical filling equipment and operator, representing proposed changes to qualification, validation governance, investigations, and lifecycle control for 2026.

EU GMP Annex 15 Revision to Cover Active Substances: Concept Paper Highlights (2026)

EMA & PIC/S consult on revising EU GMP Annex 15 for active substances: scope, Q&V governance, investigations, CPV and GDP...
Featured image showing a high-shear granulator used in wet and dry granulation processes for pharmaceuticals.

Granulation Techniques Comparison: Wet vs. Dry Granulation

A technical comparison of wet and dry granulation techniques with focus on process control, scalability, PAT tools, and continuous manufacturing...
How to write a gmp compliant user requirement specification in pharma - featured image

How to Write a GMP-Compliant User Requirement Specification (URS)

Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...

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