by maheshbhuva | Dec 4, 2025 | 21 CFR, Analytical Chemistry, Deviation, ICH Guideline, Quality control (QC)
1. EDQM / EU GMP (Europe) ​Focus: The European approach places heavy emphasis on the Qualified Person (QP). The QP acts as the gatekeeper and must personally ensure that any deviation does not violate the Marketing Authorization (MA). ​Risk Management: EU GMP...
by maheshbhuva | Jun 6, 2023 | stability
No Only manufacturing area or production batch taken as stability Share this: Click to share on Facebook (Opens in new window) Facebook Click to email a link to a friend (Opens in new window) Email Click to share on Reddit (Opens in new window) Reddit More Click to...
