Revision of the EU GMP Guide: EU Commission Publishes Proposals for Chapters 3, 5, 6 and 8

On 17 January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide. The publication had been expected for a long time now.

Paragraph 6 of Chapter 3 Premise and Equipment has been revised and extended. It contains regulations on how to avoid cross-contamination. The changes made are tightly interlinked with the revised contents of Chapter 5 Production. The requirements expressed also refer to a new guideline on dedicated facilities which has been published recently by the EMA.

The revisions made in Chapter 5 Production can be found in the paragraphs 17 to 20. These revisions also refer the question of how to avoid cross-contamination. All the revisions now submitted as a draft have been intensively discussed between the EU authorities and the industry. In addition, paragraphs 26 to 28 on Qualification of Suppliers have also been modified. The changes take into consideration the new requirements according to which the manufacturer of a medicinal product has to ensure that the APIs have been manufactured in compliance with the GMP regulations. So-called "supply chain security" requirements have also been added. Now, the drug manufacturer must also ensure that all the starting materials used originate from controlled sources. Moreover, there are new requirements now with regard to the control of starting materials and the obligation to inform authorities when a medicinal product is no longer available for GMP reasons. We've recently reported about the topic of supply shortages caused by GMP problems in a GMP News.

Chapter 6 Quality Control now provides new requirements on the transfer of analytical methods as well as new regulations about the handling of out-of-specification results. Chapter 8 points out - among other things - the significance of a quality management system for the evaluation of quality defects in relation to product recalls and likewise clarifies the requirements regarding the reporting (when and how) of quality defects to the authority.

Detailed analyses of each chapter will be published in coming GMP News.

Deadline for comment is 18 July 2013.