sterilization validation – Pharma GMP

GMP for Medical Devices & Combination Products: A Step-by-Step, Inspection-Ready Implementation Guide

digi — Wed, 05 Nov 2025 16:44:43 +0000

GMP for Medical Devices & Combination Products: A Step-by-Step, Inspection-Ready Implementation Guide GMP for Medical Devices & Combination Products — Step-by-Step, Inspection-Ready Guide Drug–device combination products sit at the intersection of pharma cGMP and device QMS. In the US, 21 CFR Part 4 defines how manufacturers must apply both drug cGMP (21 CFR 210/211) and...

Never Ignore Pressure Fluctuations in Autoclaves During GMP Sterilization

digi — Mon, 28 Jul 2025 05:12:13 +0000

Never Ignore Pressure Fluctuations in Autoclaves During GMP Sterilization Investigate Pressure Fluctuations in Autoclaves Without Delay Remember: GMP mandates that all autoclave pressure deviations be investigated immediately—ignoring them risks sterilization failure and product integrity. Why This Matters in GMP Autoclaves are vital in ensuring the sterility of pharmaceutical products and components. Pressure fluctuations during a...