GMP compliance in pharmaceutical industry – the importance of GMP regulations
Pharmaceutical industry is one of the most meticulously regulated ones in the world. It is not a surprise given that the patients’ well-being, including their health and even their lives are at stake. Any company operating in a pharmaceutical sector must strictly follow a number of regulations in order to ensure the safety and efficacy of medicinal products. Good Manufacturing Practice (GMP) guidelines provide a set of fundamental rules which are essential to guarantee an adequate product quality.
Following the Good Manufacturing Practice, contrary to its name, is not only a good practice but an obligation for every manufacturer and importer of human and veterinary medicines. It is a set of procedures focused on reducing the risks associated with manufacturing of medicinal products and protecting the appropriate quality of each product batch. Its main purpose is ensuring the patients’ safety and the products’ expected therapeutic effect.
The principles and guidelines of GMP in the European Union are laid down in three legal acts:
- Regulation No. 1252/2014 and Directive 2003/94/EC, applying to active substances and medicines for human use;
- Directive 91/412/EEC applying to medicines for veterinary use.
Additionally, Directive 2001/83/EC and Regulation No. 2019/6 contain related provisions.
The EU GMP guidelines contain guidance for the interpretation of these principles and guidelines. They are supplemented by annexes that modify or expand the general rules for certain types of product (such as radiopharmaceuticals or herbal medicinal products) or provide more specific instructions on a particular topic (for example certification by a Qualified Person or importation).
In Poland the general GMP guidelines are specified in the Polish Act of 6 September 2001 on Pharmaceutical Law (consolidated text in Polish: Journal of Laws 2021 no. 1977). More precise rules are provided in the implementing acts to the Pharmaceutical Law. The most important of those is the Regulation of the Minister of Health of 9 November 2015 on Good Manufacturing Practice requirements (consolidated text in Polish: Journal of Laws 2019 no. 728).
Polish legal instruments are almost a direct implementation of the EU GMP into the Polish legislation. Nonetheless, they also provide a more detailed description of certain requirements relevant only in Poland and compliant with Polish administrative procedure.
Currently there are also several separate GMP systems outside the European Union – for instance in the United States or Japan. Still, their basic premises are very similar to each other.
The GMP guidelines create the fundamental basis for undertaking variety of activities in the field of manufacturing of a medicinal product. They address steps such as record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.
The GMP requirements were designed to be flexible. They are mostly very general since they describe the minimum standard that a medicines’ manufacturer/importer must meet in their production processes. This manner allows each manufacturer to individually decide how to best implement the necessary controls. Many pharmaceutical manufacturers are already implementing extensive measures in their internal quality systems and risk management procedures that exceed these minimum standards.
The implementation of the GMP rules by a manufacturer/importer is verified and confirmed by issuing an appropriate certificate by a competent authority.
A manufacturer/importer may obtain a certificate confirming their compliance with the requirements of Good Manufacturing Practice after an inspection carried out by highly trained staff from the GMP Inspection Department of the Chief Pharmaceutical Inspectorate [1].
During such inspection, it is verified whether a manufacturer/importer of the medicinal product complies with their obligations under the GMP. A certificate is issued if the inspection shows that a pharmaceutical company meets the requirements of the GMP guidelines. If the inspection reveals that a company does not comply with the GMP, such certificate is either not granted or withdrawn. Information about issuance or withdrawal of such certificate is entered into the European EudraGMDP database.
Failure to comply with the GMP may even result in revoking of the manufacturing and importation authorization, making it impossible for a manufacturer/importer to undertake any manufacturing activities [2]. In case of identifying a breach of requirements regarding the manufacturing conditions, the Chief Pharmaceutical Inspector may forbid placing a medicinal product on the market or recall it from the market [3].
The GMP guidelines constitute a unique international code of conduct all over the world. They require manufacturers and importers of medicinal products to take all the necessary steps to guarantee that their products are effective and safe. Thanks to the GMP, the pharmaceutical companies ensure that each medicinal product is of appropriate quality and contains only the proper substances in correct doses and concentrations.
Patients typically cannot verify themselves, by using their senses, if a medicinal product works or if it is safe For this reason it is crucial that such products are manufactured under conditions assuring that quality is incorporated into the manufacturing process every step of the way. To quote the US Food and Drug Administration, “facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how the GMP requirements help to assure the safety and efficacy of drug products. All of the above measures protect the patient from purchasing a medicinal product that does not provide an expected therapeutic effect or could even cause some harm.
Interested in GMP issues? Check our article about EU GMP Annex 21 and check what new doeas it bring.
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