GMP News - Validation

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.

The requirements for cleaning validation are not very clearly defined in the US GMP regulations 21 CFR 210/211. Even a Guide to Inspection on this topic dating back to the 1990s does not represent the FDA's current interpretation. Current Warning Letters on the subject of cleaning validation are helpful here.

Due to the Covid-19 pandemic personal presence of pharmaceutical customers at the supplier site has generally been reduced or even become impossible - especially for FAT. So “remote-FATs” came up more and more in the last year and are still used. But how successful are such remote FATs? What are the problems showing up? This was something we wanted to find out from you, to get an overview - and therefore a survey was set up. Find out what the survey results were.