28/29 April 2020
Prague, Czech Republic
In an interesting Warning Letter, the FDA replies to a letter from a pharmaceutical manufacturer that had received a 483 deficiency report in which the FDA criticized, among other things, deficiencies in process validation. Following you will find out more about the correspondence.
The FDA investigator specifically mentioned as inadequate that process validation consisted of tests on the first production batch and that R&D and Quality Assurance then jointly decided whether the batch could be released or not.
In its reply to the 483, the company mentioned, inter alia, that due to its variability, the production process can in general not be validated, but instead all relevant parameters are controlled by measurements.
For the FDA, this is not acceptable. With reference to the FDA Process Validation Guideline, the FDA requested a process validation that shows that the development of the process is science-based and that the process remains in a controlled state throughout its life cycle. For this purpose, each manufacturing step must be developed accordingly. The process qualification studies then demonstrate whether the initial control state is maintained. They are necessary before the product can be marketed.
For this reason, the FDA requires:
For more detailed information please see the complete FDA Warning Letter to Dental-Kosmetik GmbH & Co. KG.