A GMP certificate (German translation: GMP-Zertifikat) is the colloquial name for the “Certificate of GMP Compliance of a Manufacturer.” It is issued by the competent regulatory authority and confirms that the production of a particular company complies with the standards of Good Manufacturing Practice (GMP; translation into German: Gute Herstellungspraxis). The GMP standards are a set of regulations that define the requirements for the manufacture and quality control of drugs (British English: medicinal products). At the request of the pharmaceutical company, the regulatory authority can issue a WHO GMP certificate, as this is often required for the export of drugs.

Purpose of a GMP certificate:

• Quality assurance: Confirmation that the products are manufactured in accordance with international and domestic quality standards.
• Marketing authorization requirements: In many countries, GMP certification is a prerequisite for the approval and sale of pharmaceutical products.
• Consumer trust: The certificate increases the trust of consumers and partners in the product.
• Access to international markets: A WHO GMP certificate is often required to export products to other countries.

Procedure for obtaining a GMP certificate:

• Preparation: The company must ensure that all aspects of production, including processes, equipment, staff and production facilities are GMP-compliant.
• Inspection: The competent regulatory authority inspects the production facilities in order to verify their compliance with GMP requirements.
• Rectification of deficiencies (German translation: Mängel): If irregularities are found during a GMP inspection, the company must rectify them within a certain period of time.
• Granting a certificate: After a successful GMP inspection and rectification of all deficiencies, the company receives confirmation of GMP conformity, which is usually valid for a limited period of time, after which a new inspection and certification is required.

The GMP certificate serves not only as a confirmation of the quality of the products manufactured, but also as an important instrument for risk management (German: Risikomanagement) and the improvement of production processes in a company.

GMP-inspection.com is your experienced partner when it comes to pharmaceutical language services. As competent pharmaceutical interpreters and GMP translators, we accompany you on the way to obtaining your GMP certificate.

Our range of services also includes various types of consultancy services in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with many pharmaceutical companies around the world, we can also assist you if you are looking for a new career challenge in the pharmaceutical industry.