GMP News - Validation

Since the end of last year, the ICH Q9 document on quality risk management has been in stage 2 of the ICH process for publishing ICH documents as a draft revision 1. Now, the draft document has also been published by the FDA on its website and is available for comments.  

At the end of July 2022, the GAMP organization has published the 2nd Edition of GAMP® 5. What are the main changes and developments compared to the previous version, which has been available since 2008?

The issue of mixing uniformity has been a validation-required topic in the field of solids for years. This is even explicitly required in the US regulations (21 CFR 211.110). In a recent Warning Letter, requirements for the mixing uniformity of an active ingredient were also addressed. What did the FDA criticise?

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American manufacturer. The firm produces a United States Pharmacopeia (USP) article. The core problem was that the company deviated from the USP for analytical testing, but could not adequately demonstrate that the method is equivalent or better than the current USP compendial method.

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an American drug manufacturer. The company retested failing lots with unvalidated test methods until passing results were obtained. Other deficiencies concern the cleaning validation, the stability program and HPLC data integrity.

In our News on FDA Warning Letter Statistics for the fiscal year 2021 (October 2020 - September 2021) you could read that deficiencies for process validation are on place 5. But what deficiencies did the FDA find in process validation?

In a Warning Letter, the FDA criticises eye drops from a Chinese manufacturer for not being manufactured under sterile conditions. The manufacturer argues that it made the eye drops under non-sterile conditions as nasal drops. Of course, the FDA did not accept this argumentation. Citing the FDA Aseptic Guide, the Warning Letter shows what the FDA considers to be the state of the art in aseptic manufacturing.