4/5 October 2022
Heidelberg, Germany
In the News on FDA Warning Letter Statistics regarding the fiscal year 2021 (October 2020 - September 2021) you could read that process validation deficiencies are on place 5. But what deficiencies did the FDA find in process validation?
In total, seven companies were criticised by the FDA in a Warning Letter about process validation deficiencies in fiscal year 2021. In these letters, the FDA refers to 21 CFR 211.100 (Subpart F- Production and Process Controls, written procedures; deviations).
Five of the seven companies had no process validation, and for two companies the PPQ batches failed. Interestingly, missing or insufficient equipment qualification was also criticised three times.
In response to their Warning Letter, the FDA requested almost always
An concurrent validation, as a "quick fix" was not accepted by the FDA. Furthermore, the FDA Guidance "Process Validation: General Principles and Practices" is almost always cited as the basis for process validation and it is pointed out that a permanent "state of control" is required.