As previously discussed on the blog, Good Manufacturing Practice, or GMP is a vital consideration for pharmaceutical manufacture and quality control. This means that the processes, equipment, active ingredients, documentation and training are controlled and of a high standard prior to a drug being approved. To be in compliance with GMP, regulations should ensure that the drug substance is of adequate quality, when used in humans and becomes available commercially.
Ultimately, quality protects the public and ensures that the reality of a drug sold or prescribed is an accurate reflection of the claims and ingredients made not only on the label, but also of the exact nature of the formulation that was approved through rigorous clinical trials and analysis.
The first time GMP regulations were published by the WHO was in 1968. The rest of the developed world very quickly followed suit, and today there is an effective, if complex, system of guidelines and alliances that make possible a high level of quality control and safety in a global pharmaceutical market.
The self proclaimed ‘gold standard’ bearer of GMP is the United States Food and Drug Administration (FDA), and there are a number of reasons they are deserving of that title.
As mentioned above, in the US, GMP is known as cGMP, or current Good Manufacturing Practice, meaning a continued change and improvement of the regulations. This simple allowance in the title and wording of the guidelines implies that in order to adhere to the minimum standards, a manufacturer must take into account the presently available equipment, procedures, advice and developments. While the guidelines have not been fully re-issued since 1976, they have evolved since their inception as part of a continuous discussion between regulators, cGMP inspectors, drug developers and manufacturers for almost 35 years.
A second strength of the US system is the stringency with which cGMP is enforced and the broad scope of definition open to non cGMP compliance.
Drugs are approved based not only on their clinical trial data but on the entire process used to produce and analyse them; from ingredients to packaging, labeling and transport. Any deviation from this process can have the product seen as ‘adulterated’ and seized, recalled, or even be the catalyst for the commencement of criminal proceedings. While this is rarely pursued, it is a firm indication of the strength of US cGMP and a definite re-assurance to the public in relation to the quality of their drugs.
A final point that may seem trivial, but one that is deeply ingrained in both American democracy, and the superior functioning of the FDA’s cGMP, stems from the freedom of information act.
The reports of all cGMP audits and inspections are publicly available. This simple fact means that no manufacturer can be unaware of the FDA’s current position in relation to manufacturing standards and processes. Indeed a lucrative industry has been built around the simple fact that this information is available and the quick and insightful analysis and comprehension of it is invaluable to drug developers and manufacturers in the US and beyond.
For more on GMP, we’ve just released a new webcast on GMP featuring Clinuvel Non-Executive Director Jack Wood. Click here to listen.
Image reference:
http://www.flickr.com/photos/tacitrequiem/2918675702/
