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Saturday, September 20, 2025

What is Continued Process Verification

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# Ongoing Process Verification: A European GMP Inspector's Essential Guide In the evolving landscape of pharmaceutical manufacturing, **...
Tuesday, September 16, 2025

Investigation Models

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When conducting an investigation, the type of reasoning you use depends on the nature of the problem, the available evidence, and the goals ...
Monday, September 15, 2025

Annex 22: Artificial Intelligence in GMP – What Pharma Needs to Know

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Annex 22: Artificial Intelligence in GMP – What Pharma Needs to Know Artificial Intelligence (AI) is rapidly transforming pharmaceutical man...

EU Aneex 22 AI/ML Artificial intelligence and Machine learning

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Understanding "Human-in-the-Loop" in Pharmaceutical Manufacturing In the evolving landscape of pharmaceutical production, the inte...
Saturday, September 6, 2025

EU GMP Chapter 1 Revision: Key Updates and Stakeholder Consultation

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The European Commission has announced a targeted revision to Chapter 1 of EudraLex Volume 4, the EU Good Manufacturing Practice (GMP) Guidel...
Thursday, August 28, 2025

Unlocking Competitive Edge: How Digital Maturity Empowers CDMOs to Secure More Sponsor Contracts

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In the fast-paced world of contract development and manufacturing organizations (CDMOs), compliance isn't just a box to check—it's a...
Wednesday, August 27, 2025

Final Revised Good Agricultural and Collection Practice (GACP) Guideline Published: What You Need to Know About Revision 1

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**Posted on August 28, 2025** Hello, GMP compliance enthusiasts! If you're involved in the world of herbal medicinal products, you'v...
Monday, August 25, 2025

US FDA WL to Indian pharm company after fire accident

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Access WL The recent FDA warning letter to an Indian manufacturer of active pharmaceutical ingredients (APIs) highlights major Good Manufact...
Monday, August 4, 2025

US FDA Glenmark Pharmaceuticals Limited 2025

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The United States Food and Drug Administration (FDA) issued a warning letter to Glenmark Pharmaceuticals Limited on July 11, 2025, following...
Thursday, July 24, 2025

Test User Reg

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