Annex 15

The EU GMP Guidelines are changing!

History of significant EGMP Guideline changes that occurred in 2014

This is a historical document about changes to EU GMP guidelines that occurred in 2014.

A number of very important changes are taking place within the EU GMP guideline from October 2014, with key chapters in the Eudralex Volume 4, Part 1 have been revised and come into effect soon. These changes reflect the current thinking of the European regulators and the industry as a whole in providing greater control over critical processes in the pharmaceutical product lifecycle.

Firstly, the revision of Chapter 3 – “Premises and Equipment” and Chapter 5 – “Production” will come into operation in March 2015 and will incorporate greater use of Quality Risk Management in the prevention of cross-contamination. The key to these changes are in addressing cross-contamination in the design, maintenance and operation of pharmaceutical processes, equipment and facilities, with a particular note on the use of organisational controls such as campaign manufacture. There is less definition of the types of products requiring dedicated facilities, however, the requirement for such facilities is still a consideration if the above mentioned controls are ineffective or not comprehensive. For cleaning validation, toxicological-based limits rather than what are sometimes described as “arbitrary limits” are now required. It is no surprise that Quality Risk Management is the key in mitigating cross-contamination concerns!

Chapter 6 – “Quality Control” has just come into effect from October 2014 and has an added section detailing requirements for appropriate and well-documented technical transfer of Quality Control tests and assays. Of particular note is the detailed requirements for selection and maintenance of reference standards, reagents, culture media and test micro strains. Make sure your assays and tests have been appropriately transferred and the documentation is available as supporting evidence, where required.

Finally, Chapter 8 – “Complaints, Quality Defects and Product Recalls” has been overhauled to incorporate the use of Quality Risk Management principles in the addressing Complaints and Recalls. Application to product defects is also more clearly defined within the requirements. The take home message from this chapter update is that the approach to issue management i.e. CAPA needs to be adopted using all relevant tools and methodologies such as risk assessment and root cause analysis.

Remember, these changes reflect the intent of ICH Quality Guidelines, so don’t be surprised if you see the changes in these Chapters being adopted by the PIC/S participating authorities in the near future.

Update dinners in 2014

Changes were discussed at the following Industry Update Dinners:

Auckland, New Zealand – Monday 10th November 2014

Sydney – Tuesday 11th November 2014
Melbourne – Wednesday 12th November 2014
Adelaide – Thursday 13th November 2014