Summary of the new EU GMP Chapters and Annexes

The last year was an interesting year for those who have to have an eye on GMP regulations in the European Union. The EU GMP Guide is under constant revision. Here is an overview:

Effective since January 2013 is Chapter 1 Pharmaceutical Quality System and Chapter 7 Outsourced Activities. Some of the changes in chapter 1 are very comprehensive. This already becomes clear from the title, which was changed from "Quality Management" to "Pharma Quality System". Also CAPA principles and requirements for a Quality Manual and a Management Review have been included. The changes introduced in the revision of Chapter 7 are obviously designed to intensify the control of Contract Acceptors by the Contract Giver and extend those controls to subcontractors.

On 16 February 2014, the new Chapter 2 Personnel will become effective. The basic principles of chapter 2 have been unchanged; however a few new topics have been introduced like for example a more important role of Senior Management. The new chapter accommodates the trend in pharmaceutical industry to move more and more quality related tasks to a quality assurance department. In the old version, which will now be replaced, a lot of quality related responsibilities were assigned only to the Head of Quality Control and the Head of Production. Now, additionally and depending on the size and organisational structure of a company, a "separate Head of Quality Assurance or Head of the Quality Unit may be appointed". In this case, some of the responsibilities can be shared with the Head of Quality Control and Head of Production.

In January 2013, the EU Commission published the drafts of 4 revised chapters of the EU GMP Guide.

• 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 and its requirements regarding the prevention of cross contamination. The requirements expressed also refer to a new guideline on dedicated facilities which has been published recently by the EMA.
• Additionally, Chapter 5 includes new expectations for Qualification and auditing of suppliers supply chain traceability
• 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 on Complaints, Quality Defects and Product Recalls 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. (see GMP News on revision of chapter 3, 5, 6 and 8)

Very important for those involved in batch release is the revised Annex 16 Certification by a Qualified Person and Batch Release. This draft points out ultimate responsibilities of the Qualified Person and duties which could be delegated.

Detailed analyses of each chapter are published in the respective ECA GMP News.