Irrelevancy of GMP and facility inspections practices hence their failure – bungled-up law enforcement!

The main intend of GMP implementation is to ensure that manufacturing facilities are capable of manufacturing quality products. There exists some confusion mostly in the minds of inspectors, and corresponding experts and consultants, that the purpose of GMP is to enforce implementation of standards/specifications (or “compliance”) as per the regulations, not the assessment or evaluation of product “quality”. This, however, is an incorrect interpretation of the law and regulations. Below are citations from some of the major regulatory authorities defining the GMP, which clearly includes inference to “quality”. Therefore, GMP requirements and practices clearly relate to or require establishing the “quality” of the manufactured products.

On the other hand, it is also a fact that at present a scientific and/or enforceable definition/description/criteria for establishing and assessing “quality” of pharmaceutical products, in particular tablet and capsules, is unavailable. Therefore, requirement and practice of GMP at present not only becomes weak but also unenforceable.

In general, scientifically and logically, most outcomes of a facility inspection (e.g. FDA 483s) should be considered irrelevant and invalid in establishing good manufacturing practices as well as reflection on the quality of the manufactured products. Regulatory authorities around the world, including from developed economies, should take note of this serious weakness of the current inspection practices (or law enforcement) which may not pass the test of the laws.

(1) FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its Current Good Manufacturing Practice (CGMP) regulations. (https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations)

(2) Any manufacturer of medicines intended for the EU market, no matter where in the world it is located, must comply with GMP. GMP requires that medicines: are of consistent high quality; … (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice)

(3) Good Manufacturing Practices (GMP) are the part of quality assurance that ensures that drugs are consistently produced and controlled in such a way to meet the quality standards appropriate to their intended use, as required by the marketing authorization. (https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices.html).

(4) Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. (https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/)

(5) The Good Manufacturing Practice (GMP) guidelines are a set of regulations that ensure that food, drugs, medical devices, and cosmetics are produced at a high quality.( https://www.news-medical.net/life-sciences/What-is-Good-Manufacturing-Practice-(GMP).aspx)

(6) Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. (https://ispe.org/initiatives/regulatory-resources/gmp)

Comments are closed.

Crescent-Shaped Spindle

Now Available
Click here

Archives
Links

PharmacoMechanics