GMP News - Inspections/Audits

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during a 5-day inspection of the company's manufacturing facility in Malaga, Western Australia. The core issue is the non-compliance with requirements specified in the United States Pharmacopeia (USP).

The PIC/S has published a draft Recommendation on risk-based change management within the PQS.

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

Deviations and CAPAs are still hotly debated topics in GMP inspections. This is shown once again by a recent FDA Warning Letter.

Once again, an Indian pharmaceutical manufacturer has received a Warning Letter from the US-American FDA due to deficiencies discovered during an inspection. The Letter focuses on deficiencies in the validation and the handling of OOS results in the laboratory. Read more here

Quite a few authorities in the health care sector come for GMP inspections, also to foreign countries. Here you can read what the Brazilian ANVISA will expect.

The Mutual Recognition Agreement (MRA) between the EU and the US is now in force as planned. But does this really mean the end of all FDA Inspections in the EU?