Comments from the recent MHRA and Pharmig Conferences

The FMD is now a legal requirement and a full update was provided at the MHRA conference in December. The focus on API audits and GDP were discussed as was the requirement for excipient GMP. Both these activities are placing demands on pharmaceutical manufacturers and will continue to be a focus for the MHRA Inspectors.
The conference also saw communication of the new Orange guides (EU GMP guide) and this includes the recently updated GDP guide. At 600+ pages and a cost of £60+ it is a must for all MIA and WDA holders as well as QPs and RPs
The 21st Pharmig conference had a record attendance with in excess of 70 delegates, 25 exhibitors plus committee members and international speakers. The conference was very well received. It was my last as chair of Pharmig and a great way to end my tenure. I was very humbled to be made an honorary member of Pharmig and received a great send off from the committee, friends and colleagues. I will continue to support Pharmig and there is the PCT event on 13th February 2014, plus I will be hosting a water meeting in March 2014.
Please let me know if MQAS can be of service to you or your company and contact me via the web site or LinkedIn

Important Industry Diary Dates

The 2/7/2013 deadline has passed for the Falsified Medicines Directive and the need requirements for API manufacturers outside the EEA. Check out the MHRA web site for those countries ‘white listed’ and those requiring Letters of Confirmation. Focus is now moving toward manufacturers and suppliers of excipients.

The MHRA have also communcated the dates for their annual GMP & GDP conference on 2, 3 & 4th December 2013. This promises to be a key event for those working in the pharmaceutical industry. I hope that I will have the opportunity to meet with you at the event.
Finally in this update I can also confirm the dates for the Pharmig conference i.e. 20 & 21st November at the Oxford Belfry. Please check out the Pharmig website at  www.pharmig.org.uk or catch me on Linked In.

Keeping Abreast of Pharmaceutical Industry Initiatives

The PQG/MHRA held their annual Q&A meeting in London on 19th March and it provided the opportunity for PQG members, mainly QPs, to raise questions for discussion with the MHRA. As always, it was a great opportunity to learn and share information.

We need to review the FMD Excipient GMP guidance currently in draft for comment, and also the revised chapters of the EU Guide.

As we move towards the deadline of 02/07/13 for new rules on importation of API from outside the EU there are still unanswered questions for the pharmaceutical industry. Watch this space!

Finally, following on from the success of the Making Cosmetics Exhibition there is the possibility of establishing a Making Pharmaceuticals Exhibition, and through my work with Pharmig, MQAS will be involved in how this may develop.

The Falsified Medicines Directive – are you prepared?

New legislation was introduced on 2 January 2013 as part of Directive 2011/62 EU. This legislation will impact on most aspects of the pharmaceutical supply chain. There are implications for MA, WDL and MIA holders as well their excipient and active suppliers. Consideration will be given later to packaging.

The most immediate impact is for excipient and API manufacturers and suppliers with additional requirements for the application of GMP/GDP.

The MHRA have updates and further detail on their web site. Are you familiar with the requirements and do you have an action plan?