EU Good Distribution Practices (GDP) Guideline of Medicinal Products for Human Use finalized

After public consultation in 2011 and further adjustment in 2012 the new version of the EU GDP Guideline of Medicinal Products for Human Use has been finalized and published in the Official Journal of the European Union (08.03.2013).
Besides ensuring compliance with Good Manufacturing Practices (GMP) participants of the pharmaceutical supply chain need to increasingly focus also on adherence to GDP principles in order to ensure appropriate product quality from the manufacturer to the (end-) user. These requirements have inter alia been strengthened by related changes promulgated by Directive 2011/62/EC.
The following bullet points summarize the current status of GDP guidelines for Medicinal products, APIs and excipients on a global level and provide the related links to the documents:

Excipients: EU Draft Guidelines for formalized risk assessment ensuring appropriate GMP published for public consultation

The long awaited Draft guideline has been published in February for public consultation by end of April 2013. The guide consists of three different sections covering

  • Determination of appropriate GMP based on type of excipient
  • Determination of Excipient Manufacturer´s Risk Profile
  • Confirmation of Application of Appropriate GMP

The guide requires Manufacturing Authorisation Holders in cooperation with their suppliers/manufacturers of excipients to create and maintain documented evidence about the analysis and ongoing management of appropriate GMP compliance of the sued excipients for medicinal products for human use. For this purpose Quality Risk Management principles and guidelines (e.g. ICH Q9) have to be applied.

Accreditation / Certification – definitions and potential benefits

The terms “accreditation” and “certification” are increasingly used also in pharmaceutical publications e.g. the EU DRAFT Guideline for the formalized risk assessment of excipients states: ”Quality system certification or accreditation held by the excipient manufacturer“ or EXCiPACT™ “is a voluntary international scheme to provide independent 3rd party certification of manufacturers, suppliers and distributors of pharmaceutical excipients.” The definition of accreditation is clearly given by the ISO standard 17000 as follows:

„Third party attestation related to conformity assessment body (CAB) conveying formal demonstration of its competence to carry out specific conformity assessment tasks”

An accredited body has therefore independently been assessed for competence in a certain field of service. Therefore such accreditation can serve as further evidence for professional supplier qualification.
Further reading:

Major GxP Events II/2013