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Monday, June 30, 2025

FDA WL on Memory based working

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Here’s a rewritten and detailed version of the FDA Warning Letter topic for your blog: --- 🧪 “Memory‑Based Manufacturing” and the Critical ...

Key Issues Identified in the FDA Warning Letter to AACE Pharmaceuticals

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The U.S. Food and Drug Administration (FDA) issued a Warning Letter to AACE Pharmaceuticals, a U.S.-based company, on April 9, 2025, followi...

Is Knowledge Management Part of the Pharmaceutical Quality System?

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In the pharmaceutical industry, maintaining high-quality standards is critical to ensuring safe and effective products. A key component of t...
Thursday, June 12, 2025

US FDA WL on Microbiology OOL

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The company experienced seven out-of-limit (OOL) events for microbial content in a system used to generate a major component of drug product...
Monday, June 2, 2025

ICH: New Guideline for Stabilities

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The draft guideline "STABILITY TESTING OF DRUG SUBSTANCES AND DRUG PRODUCTS" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION O...
Sunday, April 6, 2025

Validation Master Plan and Validation Protocols Correlated

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The FDA found that although there were requirements in the Validation Master Plan for process validation and hold times, no operating condit...
Sunday, March 23, 2025

WHO: Updates on Method Transfer

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In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology ...

Root Cause Analysis and FDA WL

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Your firm failed to conduct adequate manufacturing investigations into out-of-specification (OOS) results obtained by your external laborato...

Cleaning Validation and FDA WL

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SOPs on Cleaning Validation not followed The FDA criticizes that the cleaning validation for non-dedicated equipment and its maintenance are...

Warning Letter - Deficiencies in the Control of Raw and Starting Materials

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The FDA has investigated the hi u need it ugtygsyjthz yubsybh fhgjeg bb manufacturiyng practices of Shantou Kangjie Daily Chemical Industry ...