FDA releases new requirements on validation process: a warning letter
The new guidelines released by FDA will change the idea of a validation process. Validation is a three-stage process of establishing documentary evidence demonstrating that a whole process of drug development and production achieves the desired level of compliance at all stages.
FRA refers to 21 CFR (Code of Federal Regulations) 211.100 (a) and criticizes pharmaceutical companies for not ensuring consistency and reliability of the of drug development and production lifecycle. As a result, batches of one product may considerably differ in strength, quality, and purity. One validation report includes a retrospective assessment of an individual process performance qualification batch. This batch was sold out in 2015 despite a number of deviations from quality were found. The report was published in 2017 right before the FDA proclaimed the results of their examination.
Therefore, the FDA criticizes that potential process deviations, which must be properly controlled so that to ensure consistent quality and reproducibility of the process, were not monitored.
Finally, the FDA indicates that any kea process step should be structured so that the raw materials used, the in-process material and the final product meet all quality requirements. Validation assesses the consistency of product development and further maintenance of production during a life cycle of the product. Regular monitoring of product performance and quality of the final product are also of high importance to guarantee the stability of the whole process.