GMP stands for Good Manufacturing Practice. GMP is a set of rules that must be observed and complied with in the manufacture of medicinal products and active ingredients. The aim of GMP is to ensure consistently high product quality in accordance with the specifications. This ensures patient safety, the most important objective. There are also good manufacturing practices for cosmetics and food, but these are different sets of regulations. At PTS, we use the term GMP to refer exclusively to medicinal products and active ingredients.
The most important legal regulations in the pharmaceutical environment are the German Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV). The AMWHV requires compliance with GMP rules in the manufacture of medicinal products and active pharmaceutical ingredients and refers to the EU GMP guidelines. This is the document, or rather the collection of documents, that contains the GMP rules. The EU GMP guideline itself is not a legal requirement. However, as the AMWHV requires compliance with this guideline, it indirectly becomes a mandatory legal requirement.
To ensure product quality, it is important that all persons directly or indirectly involved in production comply with GMP regulations. This also applies to employees of external companies. What does this mean in detail? Among other things, employees must know all the instructions and regulations they need for their work. Each individual must understand what he or she is responsible for and what effects their own work can have on the quality of medicinal products (and active ingredients). This knowledge and understanding must be conveyed through training.
There is a training plan to ensure that everyone receives the training they need on an ongoing basis. The training plan defines how each employee is to be trained in GMP and operational procedures. All employees must receive regular GMP training in accordance with the training plan, e.g. on the topics of documentation, hygiene or quality management.It is important and required to regularly refresh and deepen this knowledge and to inform employees of current changes. Of course, the success of the instructions must be checked, which is done with so-called success controls.
What is not documented has not taken place. You may be familiar with this saying. The idea behind it is that everything in the GMP environment must be documented, including training courses. To this end, PTS issues a certificate of attendance for the participants. If the participant successfully completes the optional performance review, he or she receives a certificate of attendance confirming successful participation in the event.
