Good manufacturing practice (GMP)

Good manufacturing practice is the body of principles and guidelines ensuring that medicinal products are consistently produced and controlled to quality standards appropriate to their intended use and in accordance with their authorisation. It is required by Directive 2001/83/EC, specified in a Commission directive and set out in detail in a European guide published in Volume 4 of the rules governing medicinal products in the Union (EudraLex). In France, the ANSM publishes its text by decision and monitors its application.

Scope of the obligations

Good manufacturing practice applies to every manufacturer holding a manufacturing authorisation, including an importer established in the Union which releases batches manufactured in a third country. It covers the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, outsourced activities, complaints and recalls. Each batch must be certified by a qualified person before release. Active substances used as starting materials are subject to specific good manufacturing practice, and their import generally requires written confirmation from the authority of the exporting country.

Inspection and sanctions

Compliance with good manufacturing practice is verified through inspections by national authorities, whose results are entered in the EudraGMDP database. An inspection leads to the issue of a GMP certificate or, in the event of a serious breach, a statement of non-compliance which may result in suspension of the manufacturing authorisation, batch recalls and supply shortages. Under French law, the ANSM has powers to issue injunctions and impose financial penalties on non-compliant pharmaceutical establishments.

Intellectual property issues

Contract manufacturing agreements must be supplemented by a quality agreement allocating responsibilities between the contract giver and the contract manufacturer. Transferring a manufacturing process requires the disclosure of know-how, which should be protected as a trade secret, since inspections and audits give access to sensitive information. The manufacture of generics or biosimilars under the SPC manufacturing waiver remains subject to good manufacturing practice, and the batch record is often decisive evidence in process patent litigation.

Key points

Good manufacturing practice governs the release of each batch and the maintenance of the manufacturing authorisation. A serious breach can interrupt supply to an entire market. In any contract manufacturing or technology transfer agreement, the existence of a quality agreement, the allocation of the qualified person’s responsibilities and the confidentiality clauses applicable to audits should be checked.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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