▼
Sunday, March 23, 2025

WHO: Updates on Method Transfer

›
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

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

Cleaning Validation and FDA WL

›
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

›
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

›
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

›
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

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In January 2025, the U.S. Food and Drug Administration (FDA) published a draft Guidance for Industry and other interested parties entitled ...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

›
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

›
Insufficient monitoring was carried out to ensure that the system was functioning properly and was suitable for production. FDA requirements...
Thursday, February 20, 2025

API Testing is also relevant for the FDA - Warning letter to Indian Manufacturer

›
Access Letter Here The system was poorly designed, e.g. with ‘blind spots’ and lack of continuous circulation, increasing the risk of biofil...