Revised EU Good manufacturing practice (GMP) Guidelines chapter 6 Quality Control published

Effective October 1st, 2014 the revised EU GMP chapter 6 “Quality Control” was published on March 28th. As reasons for the changes the inclusion of a new section on technical transfer of testing methods and other items such as Out Of Specification (OOS) results are listed. Both items are consequently covered in more detail in the new chapter with the items 6.37 – 6.41 (technical transfer) and 6.7, 6.9 & 6.35 (OOS), respectively.

For a technical transfer of testing methods a detailed protocol shall be prepared. Furthermore it shall be verified that the test method(s) comply with those as described in the Marketing Authorisation (MA) or the relevant technical dossier. The technical transfer shall be closed with a technical transfer report including potential deviations from the protocol and related investigations.

Concerning OOS and Out Of Trends (OOT) results a written procedure has to be in place and such results need to be investigated. This is required for any analytical tests results, yields, environmental controls etc.a

New General USP chapter <1083> series about GDP proposed in Pharmacopeial Forum 40 (2) covering all aspects of the pharmaceutical supply chain

The U.S. Pharmacopeial Convention (USP) has proposed a new General Chapter <1083> series about Good Distribution Practices (GDP) covering all aspects of the pharmaceutical supply chain i.e. storage, shipment, distribution, and transportation of pharmaceutical components and products. The proposed new General Chapter <1083> shall thereby replace the following current chapters:

  • <1079> Good Storage and Distribution Practices for Drug Products
  • <1083> Good Distribution Practices
  • <1197> Good Distribution Practices for Bulk Pharmaceutical Excipients

There is a series of sub-chapters proposed in PF 40 (2) to be commented by May 31st namely:

  • <1083.1> Quality Management System
  • <1083.2> Environmental Conditions Management
  • <1083.3> Good Importation and Exportation Practices
  • <1083.4> Supply Chain Integrity and Security

It shall thereby be assured, that the entire material flow from initial procurement throughout the supply chain through delivery to the end user is addressed. Besides pharmaceutical components and drug products, also medical devices and dietary supplements are covered.

  • Pharmacopeial Forum Log-in (one-time registration required)
  • For additional links to GDP guidelines see our blue newsletter 2/13

Questions and Answers document on GDP guideline for human medicinal products published

On April 1st 2014 a Questions and Answers (Q & A) document on the Good Distribution Practice (GDP) guideline of medicinal products (MPs) for human use was published by the European Commission. The document contains 25 Q & As. Further reading concerning the Q & A document is recommended with the following links:

Major GxP Events II/2014