One thing is for sure: It will not get boring in 2014. The further development of the EU Guide to GMP is a continuously ongoing process. Revised versions of a number of chapters were published as drafts last year. By now the consultation periods are closed and we can expect the corresponding final documents in the near future. A trend that has already been set in motion during the last couple of years continues: GMP requirements will more and more apply to suppliers by focusing on the responsibilities for quality assurance within the supply chain, e.g. for excipients and APIs. Which guidelines can be expected in 2014? We have put together information provided by the regulatory authorities and out of discussions with experts from the pharmaceutical industry. As usual, the GMP Conference also offered a comprehensive summary of the current status and an outlook. The results of the meeting held by PTS Training Service in Dusseldorf last December have also been incorporated. Find a brief summary below about new regulations and guidelines which can be expected in 2014. We will keep you informed in detail in following issues of our newsletter.
The revised Chapter 2 on Personnel will come into operation February 16, 2014. The changes were made in order to integrate the principles of “Pharmaceutical Quality System” as described in the ICH Q10 tripartite guideline. It contains precise definitions of responsibilities. The ultimate responsibility to ensure an effective Quality Management System is in place and responsibilities and authorities is with the senior management. Furthermore, new sections on the responsibilities of key personnel and consultants have been added.
Last year the European Commission closed the public consultation on the following chapters of the GMP Guidelines Part I and has published the comments:
Update on Annex 16:
In February 2013, the EC published the "Guidelines on the principles of good distribution practices for active substances for medicinal products for human use" for public consultation. The consultation period has been closed and the comments were published. The draft is based on the requirements of ICH Q7 or Part II of the EU GMP Guide. It clarifies activities that fall into the GDP area (e.g. importing, supplying or exporting APIs) and activities that are subject to the GMP Guidelines (e.g. repacking, relabeling of APIs).
The comments on the new EMA Draft Guideline “Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use” were published last year. The 5 page document notes that adequate risk assessment for excipients should be part of the Quality Management System of the product owner. Furthermore, companies importing medicinal products should have documentation on site showing appropriate GMP levels.
A PIC/S Expert Circle has prepared a PIC/S GDP Guide which is currently under consultation within the organisation. The document is based on the EU GDP Guide. It It is a voluntary guidance for non-EEA participating authorities of PIC/S.
Annex 3 to the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments will be adopted after review by the competent Working Group of all comments to the final draft.
The FDA - in particular the Center of Drug Evaluation and Research (CDER) and Center of Biologics Evaluation and Research (CBER) - continuously pursues the path of internationalisation. In this context the two initiatives FDASIA (Food and Drug Administration Safety and Innovation Act) and GDUFA (Generic Drug User Fee Act) are relevant (more details in one of the upcoming LOGFILEs). The 21st Century Initiative will be further pursued, foremost the risk- and science-based decision making for challenges in the pharmaceutical industry. Over the last years CDER and CBER highlighted the two core principles for the discussion.
One could change a popular saying: “Only something backed by a risk analysis, is plausible.” A dependable risk analysis needs sound scientific data.
Furthermore, the implementation of the 21 CFR 4 “Combination Products“ is of great importance for many companies. Next to compliance of GMP guidelines (21 CFR 210/211) organisations also will have to adhere to medical device guidelines (21 CFR 820).
The year 2014 will probably not unveil any transforming ideas. That being said, the industry has to do its homework regarding the following areas:
Nevertheless, this year offers interesting challenges for all parties involved, for regulatory authorities as well as the pharmaceutical industry and their suppliers.
19th GMP Conference, December 2013, Dusseldorf, held by PTS Training Service
New version of Chapter 2 of the EU Guide to GMP:
Draft revisions of Chapter 3, 5, 6, 8:
Draft Annex 16:
EC: GDP for APIs:
EMA: Guideline for Excipients
FDA: 21 CFR 4
Maas & Peither AG, GMP Publishing
Maas & Peither AG, GMP Publishing
Peither & Consultants GmbH