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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 ...

No further Extension of GDP Certificates in 2025 by EMA

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Background During the COVID-19 pandemic, various exemptions were introduced for GDP inspections as well as for the validity and extension of...

Guidance Documents on Variation Notifications Updated

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On the website of the HMA (Heads of Medicines Agencies), under the heading "Variations", you will find the "Guidance Document...

New Guidance for Industry draft on AI by FDA

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In January 2025, the U.S. Food and Drug Administration (FDA) published a draft Guidance for Industry and other interested parties entitled ...
Monday, March 3, 2025

Tyche Industries Ltd — February 06, 2025

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Failure to record all quality-related activities at the time they are performed. Your quality unit (QU) failed to ensure the integrity of CG...
Wednesday, February 26, 2025

Vendor CoA based approval and FDA 483

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Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production. FDA requirements...