Selvinium Solutions — InsightsPractical notes on GMP compliance, Revised Schedule M, qualification and validation, and regulatory inspections.https://selvinium.in/en-in© 2026 Selvinium SolutionsYour media fill is only as good as its worst-case rationalehttps://selvinium.in/insights/media-fill-worst-case-rationale/https://selvinium.in/insights/media-fill-worst-case-rationale/A passed media fill proves very little if the simulation was easier than the process it represents. What the justification has to establish.Wed, 24 Jun 2026 00:00:00 GMTSterile ManufacturingHimansu KhandhediaWriting a CAPA that actually closeshttps://selvinium.in/insights/writing-a-capa-that-closes/https://selvinium.in/insights/writing-a-capa-that-closes/Most rejected CAPA responses fail for the same three reasons. None of them is the corrective action itself.Wed, 06 May 2026 00:00:00 GMTQuality SystemsHimansu KhandhediaRevised Schedule M: where sites actually failhttps://selvinium.in/insights/revised-schedule-m-where-sites-actually-fail/https://selvinium.in/insights/revised-schedule-m-where-sites-actually-fail/The gaps that show up repeatedly are rarely the ones sites budget for. A look at what separates a passed inspection from a deferred one.Thu, 12 Mar 2026 00:00:00 GMTRegulatoryHimansu Khandhedia