Validation – what it really means!

It is really hard to believe or accept how people have been blind-sided with “validation” (re-validation, continued validation etc.) requirement. 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). If one does not have a reference product with known parameter and its value, then it is impossible to validate anything. Please, people this is logic and science 101.

If anyone is requiring or conducting validation without a reference (as in the case of current practices of manufacturing of quality pharmaceutical products in particular tablet/capsule), then 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 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 which would allow the manufacturers to meet or exceed the standards of quality.

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