Tag: Validation Lifecycle

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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 titled ‘What Is GAMP 5?’ showing a laboratory software engineer working at a computer with code on screen, used for an article explaining GAMP 5 risk-based validation, software categories, and regulatory alignment.

GAMP 5 in CSV: Definition, Categories, and Pharma Guidelines

Understand GAMP 5 with simple guidance on lifecycle control, validation deliverables, software categories, and risk-based decision-making in GMP environments....

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