Warning Letter: FDA criticises Missing Re-Validation

The FDA has recently issued a Warning Letter to criticize, among other things, the lack of revalidation at a pharmaceutical manufacturer. At first sight, this seems surprising, as stage 3 of the process validation lifecycle, the Continued Process Verification, replaces the periodic re-validation that was common in the past (exceptions are made in the sterile area). What are the reasons for FDA's request?

The answer is quite simple, it is not about a periodic re-validation, but the FDA criticizes in this case that the manufacturer operates the process at a new location without having re-validated the process at the new facility. The FDA also criticizes that the manufacturer's change management system in connection with the relocation was inadequate. The pharmaceutical manufacturer considered the original validation as given and sufficient.

The Warning Letter contains another interesting point of deficiency. One process was not validated, arguing that it was comparable to another process that was validated. However, both processes use different APIs and preservatives. And this is exactly why the FDA did not accept the analogical conclusion. The manufacturer offered to validate the process retrospectively in its response to the FDA. The FDA rejected this as well because the product manufactured with this process showed quality defects. In this respect, the FDA requires a state-of-the-art validation with reference to its process validation guideline and, of course, measures to ensure that the above-mentioned defects are not repeated.

Also read the complete FDA Warning Letter to Eosera, IINC.