It is really hard to believe or accept how people have been blind-sided by “validation” (re-validation, continued validation, etc.) requirements. The simple fact is that to run validation for any process; one requires a reference product or parameter to show that process is validated (or capable of providing an expected outcome or product). It is impossible to validate anything if one does not have a reference product with a known parameter and its value. Please, people, this is logic and science 101.
If anyone requires or conducts validation without a reference (as in the case of current practices of manufacturing quality pharmaceutical products, in particular, tablets/capsules). In that case, validation of such manufacturing processes must be considered as “abracadabra” practices commonly accepted as meeting the “compliance,” “harmonized standard,” etc., and do not link to the quality aspect of the process or product.
I hope authorities, including pharmacopeias, will work in addressing these bizarre trends of validation approaches/concepts currently in practice and/or required, which have no scientific and/or logical basis.
Please, define a quality product and then provide a reference product that would allow the manufacturers to meet or exceed the standards of quality.