Quality Fraud!

One cannot avoid being part of it. It is the regulatory agencies’ (e.g. FDA) and pharmacopeias’ (such as USP) practices and requirements to use the non-validated/non-qualified (hence non-GMP) testers and tests causing the fraud. Any claim with respect to quality of the products, in particular tablet and capsule for both brand-name and generic products, has to be false.

Blaming and punishing the industry for product quality and manufacturing are not relevant or valid and would not help. Education, advice and help are needed at the authorities and pharmacopeias in defining quality and setting its standards and specifications (1, 2).

I will be happy to explain the issues with quality assessments in detail and can provide solutions to address them (link).

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