Beware of GMPiers!

These are often visitors to manufacturing facilities under the titles of investigators, inspectors, auditors, consultants, experts, compliance officers, etc. (internal or external to the regulatory agencies). Logically and scientifically speaking, at present, they provide absolutely no useful or valuable purpose for the development, manufacturing and assessment of pharmaceutical products such as tablets and capsules but hindrance, delays and exuberant cost to industry and by extension to consumers/patients. Their observations and conclusions are based on subjective and narrative discussion not on any scientific, measurable or quantifiable assessments. Most often, their outcomes are filled with fancy catch phrases or acronyms such as cGMP, validations, CSV, data integrity (DI), record-trailing, inappropriate SOPs, improper documentation, root cause analysis, CAPA, which in general are book/record keeping (admin/clerical) exercises mostly unrelated to quality of the products and/or quality of the manufacturing.

Note that any deficiency or observation, unsupported with corresponding direct and/or validated evidence to quality of products or their manufacturing (which often is the case) must be rejected as superficial or irrelevant. Industry should protect expertise and academic credentials of its employees and manufacturing competence from these “visitors” which often lacks the needed expertise to assess facility operations and/or quality products manufacturing.

Seek help in protecting your expertise and manufacturing of quality products with scientific evidence, knowledge, and support.
The following provides some links to articles describing basis of irrelevancy of often reported deficiencies.

(1) Biggest violators of GMP (link)
(2) Can Regulatory And Pharmacopeial Compliance Practices Establish Quality? (link)
(3) Consumers and patients must wait, and suffer, for the availability of quality pharmaceutical products such as tablet/capsule as well as their genuine and affordable prices. The reason may surprise you! (link)
(4) Making unsubstantiated and/or false claims by the regulatory authorities including FDA regarding quality of pharmaceutical products (link)
(5) Pharmaceutical product manufacturing as per current regulatory requirements! (link)
(6) Promoting quality standards for drug products: Scientifically speaking, please be systematic and logical! (link)
(7) Quality assessment of pharmaceutical products – regulatory/pharmacopeial standards and methods require urgent attention! (link)
(8) Regulatory/pharmacopeial assessments of quality of the pharmaceutical products – in the grip of falsehood and fraud! (link)
(9) Time to rescind the regulatory requirements of bioequivalence evaluations and the current pharmacopeial drug dissolution practices as these do not provide quality assessment of pharmaceutical products (link)
(10) Why are regulatory authorities, including pharmacopoeias, allowing and promoting (through guidance documents and seminars/conferences) the use and sale of non-GMP compliant drug dissolution testers? (link)

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