Good manufacturing practice

Quality assurance of medicinal products

In the development, manufacture and testing of medicinal products in the European Union (EU), the pharmaceutical industry is subject to high standards of quality assurance.

The marketing authorization system for medicinal products guarantees that all medicinal products that the manufacturer wishes to manufacture and place on the market are assessed by authorities authorized by the EU or EU Member States and meet up-to-date requirements for their quality, safety and efficacy.

The authorisation system for pharmaceutical manufacturers ensures that medicines on the EU market are manufactured by authorized companies, whose activities are systematically controlled by the authorities authorized by EU Member States. The manufacturing authorisation is necessary for all EU pharmaceutical manufacturers, regardless of whether they are manufacturing in the EU or third countries, as well as for partial production and/or operations related to repackaging, packaging, labelling and presentation. A manufacturing authorisation is also necessary for the import of medicinal products from third countries as medicinal products imported into the EU must be investigated/tested (with the exception of the cases provided for by the relevant mutual recognition agreements) and their batches are certified and marketed to the EU market by a Qualified Person of the EU manufacturing authorisation holder. Import activities usually consist of reception, storage, sampling, qualitative and quantitative testing of the product batches, as well as certification and release of the batches of medicinal products, and may be carried out by a holder of a manufacturing authorisation in the EEA, indicated in the registration file of the medicinal product.

Manufacturers of medicinal products, including investigational medicinal products, and importers from third countries must comply with EU requirements for good manufacturing practice for medicinal products. The manufacturing authorisation grants its holders the right to distribute their manufactured medicinal products in accordance with the requirements of good distribution practice.

In the EU, the manufacture of active substances is also subject to harmonized requirements - good manufacturing practice for EU active substances. The system for registering of manufacturers, importers and distributors of active substances (recording into the list of manufacturers, importers and distributors of active substances) ensures that the manufacture, import from third countries and distribution of active substances in the EU is carried out by authorized legal entities registered in the on the list of legal entities who carry out the manufacture on the basis of active substances good manufacturing practice and importing and distributing active substances in accordance with the requirements of Good Distribution Practices for active substances.

http://ec.europa.eu/health/documents/eudralex/vol-1/index_en.htm
http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
http://www3.lrs.lt/pls/inter3/dokpaieska.showdoc_l?p_id=460720