GMP stands for “Good Manufacturing Practice”. It encompasses regulations and sets of standards that have to be followed by all manufacturers of certain products, such as pharmaceutical products.
The object is to manufacture these products in a previously defined quality for the protection of end consumers. Therefore, GMP is the part of the quality assurance system dedicated to product quality.
Attempts to use herbs and plants for healing started early in our history. Chemicals were used more and more frequently as our knowledge increased – not always without consequences. As Paracelsus (1493-1541) said: “All things are poison and nothing is without poison. Solely the dose determines that a thing is not a poison.”
However, plain contamination has occasionally led to catastrophic side effects in the past. That is why the World Health Organization (WHO) published the first Good Manufacturing Practice (GMP) rules in 1968, with the goal of preventing such contamination and incidents.
Quality – Harmlessness – Effectiveness
With the increasing use of chemical processes and synthetically produced substances, consumer safety came into focus alongside product quality. Proof of harmlessness and thus of avoiding harmful substances in pharmaceutical products was demanded. Ultimately the question arose whether a pharmaceutical product would even do what it promises. The questions of effectiveness and the risk/benefit ratio continue to be examined today before a pharmaceutical product is approved. The GMP rules are aimed primarily at ensuring quality throughout the manufacturing process.
Contents and Requirements
The contents of the GMP rules are diverse, dealing with everything that can influence quality in production. The main GMP requirements are: Freedom from contamination, traceability and reproducibility. The following must be assured among other things: trained personnel, suitable rooms, suitable machines and equipment, clearly described production processes, reliable process control and analysis, suitable product storage and distribution, and a functioning complaint/recall system.
Nothing can be left to chance. Contamination has to be excluded or, in case of an incident, reliably eliminated.
A quick look at the GMP rules shows that implementation is challenging, because the requirements described there appear very general and not concrete. Norms, standards and recommendations do in fact have to be consulted. These are mainly published by industry associations and interest groups. Accurately interpreting the GMP rules requires a wealth of experience and background knowledge. That takes genuine GMP experts.
Naturally the GMP rules are primarily intended to have a positive impact on maintaining product quality. However, they also affect the production process as a whole and the companies in question, since they have to deal with a flood of documentation and additional audits and tests. Every new machine and each new facility has to be thoroughly examined and this examination needs to be documented in a process called qualification. The success of every production, cleaning or sterilization procedure has to be verified in a process called validation.
GMP rules have applied for a long time, not only for finished pharmaceutical products but also many other life sciences industry products. From active substances to excipients, foodstuffs, cosmetics and medical device, these and many others are all subject to the GMP rules. Thus manufacturers do not have a choice; they have to implement and follow the binding, prescribed guidelines.
There are rules of Good Storage Practice (GSP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), etc. – in short, there are GxP rules.