08.12.2014 |

LOGFILE No. 38/2014 - GMP Certificates: What do they prove?

GMP-Compliant Documentation

An excerpt from the GMP MANUAL

by Cornelia Wawretschek

Certificates as documents of proof (ISO, GMP, CEP)

Certification means investigating conformity with previously defined requirements. If conformity with these requirements is confirmed the certificate can be issued.

Where ISO standards are concerned, certificates issued by accredited bodies are important and recognised documents of proof. Conformity assessment bodies that perform inspections or that audit and certify management systems are accredited by national competent authorities, usually in accordance with ISO 17020 or ISO 17021. For instance, according to the Council Directive 93/42/EEC for medical devices, only notified bodies accredited by an EU Member State may perform the conformity assessment of medical devices and quality management systems for manufacturers of medical devices (ISO 13485) in Europe.

Contrary to the above, certificates verifying GMP conformity (GMP certificates) of organisations from the private sector, such as consulting companies, have not played an important role in the field of pharmaceuticals up to now. The only decisive proof of GMP conformity up to now has been a specific audit performed by qualified auditors such as the QP, with a comprehensive and complete audit report. In the pharmaceuticals environment GMP certificates are currently issued following a successful inspection, and they serve as proof of officially acknowledged GMP conformity.

GMP Certificates of the EU, PIC/S and WHO

What is the significance of an EU-GMP certificate?

After successful completion of a GMP inspection, a(n) (EU) GMP certificate is issued by a compe-tent national EU health authority responsible for carrying out the inspection. This certificate verifies the GMP-compliant status of the inspected manufacturing site. GMP certificates are specifically issued for particular manufacturing sites and can be limited to particular substances and/or activities in keeping with the scope of the inspection. The GMP Directives 2001/82/EC and 2001/83/EC, including their appendices, stipulate that a GMP certificate should be issued within 90 days following an inspection if the inspection confirms GMP compliance of a manufacturer.

Since national authorities differ from one country to the next with regard to their controls of active substance manufacturers, not every active substance manufacturer from third countries will necessarily have an EU-GMP certificate. In addition, an appropriate inspection by inspectors from the competent national health authorities prior to an import from such countries is only required for certain active substances (such as active substances of human, animal or microbial origin or that are produced using genetic engineering) under EU national regulations.

Therefore, a valid GMP certificate can supply the holder of the manufacturing authorisation with useful information regarding the holder’s obligation to qualify the active substance manufacturer. However, it cannot eliminate the obligation to audit the active substance manufacturer.

A GMP certificate should not be confused with the written confirmation which from 02 July 2013 onwards must be included under certain conditions with every active substance imported from third countries.

What is the significance of GMP certificates from PIC/S and the WHO?

A PIC/S-GMP Certificate attests to the successful inspection in the active substance area by a competent authority of a PIC/S member state, thus also confirming the GMP conformity of a manufacturer. The result is certified by the inspecting authority on a letterhead of that authority, and it includes a reference to a PIC/S inspection. This helps to avoid redundant inspections of the same manufacturer by other PIC/S member states. The certificate is valid for a period of two years.

WHO-GMP certification is a scheme intended to simplify the import of medicinal products into countries with little GMP regulation. WHO-GMP certificates are focused on finished medicinal products, for which reason they only take active substances indirectly into consideration.

With a WHO-GMP certificate the competent health authority of an exporting country confirms in a WHO template that:

  • The production process of the medicinal product is subject to regular GMP controls
  • The pharmaceutical manufacturer complies with GMP rules
  • The product in question has marketing authorisation (or reasons for the absence of mar-keting authorisation)
  • All information relevant to the product (including packaging and labelling) has been in-spected and evaluated by the competent authority.

GMP Certificates of other national health authorities from third countries (not EU, PIC/S or WHO)

The GMP certificates presented in the preceding sections are not the only ones in existence. Worldwide there are other GMP certificates issued after inspections by national health authorities from third countries. Certificates from Indian or Chinese regulatory authorities are mentioned here as prominent examples. These GMP certificates generally confirm that an inspection has been performed on the basis of national GMP rules. Whether or not these inspections or certificates are comparable to the EU-GMP regulations is not automatically clear and must be investigated in each individual case.


This article is an excerpt from Ch. 21 Active Pharmaceutical Ingredients of our GMP MANUAL.



Dr. Stefan Kettelhoit
blue inspection body GmbH, Münster, Germany

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