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International GMPs


The GMPs have served the pharmaceutical industry well for nearly 50 years. However there is much room for improvement. There is a need to think through what it is that the pharmaceutical industry is really doing, and why.

Until 1993, it was routine in the pharmaceutical industry when pharmaceuticals failed quality control testing to test the product again, and if it passed then to release the product to market, on the rationale that the first test must have been erroneous. No GMP guide in the world commented on this practice, and this was the industry standard world-wide, in both developing and highly developed nations. The US FDA had qualms about this practice but could not eliminate it as then US cGMP regulations either specifically did not address the matter (according to the industry) or inferred that this should not be done (according to the FDA). It took a court decision in 1993 by Judge Wolin in the case of FDA vs. Barr Laboratories for the introduction of the concept of Out-Of-Specification (OOS) test results to be recognized, and for OOS investigations to become mandatory whenever it occurred.

As of the writing of this chapter not one other GMP code mentions the need for a full investigation of an OOS, and how such an investigation needs to be performed. However, as an indication of the global nature of the pharmaceutical industry, the FDA Guideline on OOS investigation (which remember is strangely 8 years after issuance still only an “FDA Draft Guideline”) has become the norm world-wide, and is followed in countries as far apart as Belgium and Bangladesh, even though technically under US law the judge’s ruling only applies in the Northern District of New Jersey, USA..

This is just one example of where the pharmaceutical industry needs to challenge accepted practices and serious think through the relationship of risk assessment, and GMPs. There is much room for further improvement in how we manufacture pharmaceuticals.

The creation of the internationally harmonized and agreed “GMPs for Active Pharmaceutical Ingredients”, issued by the International Conference for Harmonization (the document can be found at the ICH website at provides clues as to future approaches, directions and trends in international GMP codes and GMP compliance:

  • As a result of the ICH GMPs for APIs all countries have recognized that the finished pharmaceutical product is only as good as the quality of the raw material being used, and as of 2004 the WHO has included in their GMP code the requirement for API manufacturers to be inspected as part of drug product approval.
  • Serious consideration is being given by national authorities to expand the ICH GMPs from APIs to all Excipients, recognizing that poor quality in any of the raw materials making up the finished pharmaceutical can endanger the life of the patient, or at the very least impact the quality of the pharmaceutical product.
  • ICH is now considering adding to its agenda the harmonization of GMPs for finished pharmaceutical products, such that there will no longer be a need for separate European, Japanese, United States, and World Health Organization GMP codes – and perhaps there will become a uniform approach to GMP inspections by the national authorities in their mechanisms of performing GMP inspections.




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