Tag: Qualification

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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...
Cleanroom equipment with text overlay showing comparison of qualification and validation in GMP.

Qualification vs Validation: Key Differences in GMP

Qualification vs. Validation explained for GMP professionals — clear regulatory differences, lifecycle expectations, and real-world applications across pharma systems....
IQ, OQ and PQ: Importance in GMP

IQ, OQ and PQ: Importance in GMP

Discover the importance of IQ, OQ, and PQ in GMP, ensuring equipment and systems are installed and function correctly to...
Calibration and Performance Checks of Analytical Balances

Calibration of Analytical Balances and Performance Checks

Ensure precision in QC labs with proper calibration and performance checks of analytical balances. Learn best practices for reliable and...

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