Precise documentation and mountains of paper are just as much a part of the production of medicines as protective goggles and laboratory utensils. In order to ensure patient safety, every single step of the process must be meticulously documented.
International standards and regulations ensure that the manufacture of medicines takes place in a safe and controlled environment. The standards are referred to as GMP (Good Macufacturing Practice) and cover all processes associated with the production of medicines - from the procurement of raw materials to the final inspection and storage of the product.
The main purpose of GMP is to minimize risks that can occur during pharmaceutical production, such as impurities or incorrect dosages. Precise documentation and regular inspections ensure the quality of the end product. Because every task carried out can be tracked, the quality system also helps to continuously optimize the production process. In addition to quality, efficiency can also be increased as a result.
Another key advantage of GMP is that companies can build trust and prevent legal risks by complying with the guidelines. Companies that produce in compliance with GMP meet international standards and can distribute their products worldwide. However, the introduction of a GMP system and consistent compliance with all regulations involves a great deal of organizational effort and investment in technology, training and infrastructure. However, this enormous effort is offset by indispensable advantages that make GMP the foundation of pharmaceutical production.
How do you achieve GMP?
A company must fulfill a whole series of requirements before it can obtain GMP certification. First of all, a prototype of a drug is required that has been developed to such an extent that its formulation will not change much. A clean and controlled environment is required so that the drug can be produced and tested in clinical trials. InnoMedica has therefore built its own clean room at the production site in Marly, which is rare compared to other pharmaceutical start-ups. Thanks to its own cleanroom, known as the Nanofactory, InnoMedica has two decisive advantages: Flexibility and lower costs. The filling of a drug alone has to be registered several months in advance if it is ordered externally. In an in-house production facility, production can be controlled much more flexibly. In addition, the costs for external production and filling orders are prohibitively high. Investing in your own cleanroom is therefore also worthwhile financially.
In addition to a safe production environment, a quality system must be developed for GMP certification. Sand Standard Operating Procedures (SOPs), which are comparable to detailed instructions, such as the correct cleaning of the cleanroom or the use of a machine, are an essential part of this. The second cornerstone is tracking, whereby every single activity is recorded in logbooks. This is particularly important if something occurs that is not planned. In this case, it is referred to as an event. As the SOPs are very detailed, there are countless possibilities for potential events, such as if the drug solution is stirred for too long or the temperature is too high or too low. Based on a comprehensive risk assessment, a decision is then made as to whether or not the event has an impact on the quality of the end product. This is where the so-called CAPAs (Corrective and Preventive Action) come into play. They determine how the process is adapted so that the unplanned event does not occur again in the future.
After registering for certification with Swissmedic, an inspector decides whether to approve or reject the application. If a company receives certification, another inspection takes place every two years. InnoMedica achieved GMP certification in 2015 and has been able to maintain it ever since - in parallel with the construction of the clean room and its own automated filling system.
