2016 Review

2016 has seen the significant update to Annex 16 of the EU GMP Guide and the roles and responsibility of the Qualified Person (QP). This continues to add to the importance of the QP in the assurance of safety, quality and efficacy of medicines. QPs and Regulators are working to the new requirements and please contact MQA if we can support your implementation.

In addition there has been continued focus by regulators on quality, GMP and data integrity compliance both inside and outside the EU. The importance of API GMP and GDP across pharmaceutical supply chains is another area of focus for QPs in all operations.

MQA have been active in auditing and training in 2016 in personal care operations and the application of ISO 22716. Please contact us if you require assistance for these audits.

Summer Update 2015

The start of 2015 sees a transition from working with Custom Pharmaceuticals to working with Dr.Reddy UK on the importation/packing of solid dose product. MQA Solutions have also had the opportunity to work with Pharmig and NSF DBA.
2015 is a year where there are updates to several EU GMP Chapters and Annexes. Already updates have come into force for Complaints and Production cGMP and October sees a major revision to Validation. As QP’s and professionals within the pharmaceutical industry these updates place increasing emphasis on CPD and staying upto date.
Please contact MQA Solutions if we can help with your training or auditing requirements or advise on QMS improvements.

 

Winter 2014 Update

As we approach Christmas and the end of 2014 there is time to reflect on the changes in our industry. The year has seen the introduction of new guidance for QC Laboratories and Chapter 6 and the increasing importance of Data Integrity throughout all aspects of pharmaceutical manufacture. Risk management and the importance of the quality management system are again highlighted by audits, auditors and regulators.
The MHRA symposia in December and a new update to the Orange Guide will offer the opportunity to update ourselves and prepare for 2015.
2015 promises to be a busy year for MQA and I will be supporting Pharmig at several events…check out the link to their web site for a full events update and I will be working with other organisations in both a training and QP release role.
Please contact me if we can be of assistance to you….
Best wishes
Tony

MQA Spring Update

I am delighted to report that I have had the opportunity to work with Brighton University as an honourary lecturer on their MPharm and MSc courses. The course content has been delivered as a range of lectures and workshops on QA and the role of the QP in the pharmaceutical industry. The first year of this new training has been well received and it is expected that the course will run again in 2015.
Focus on training and professional development is a key criteria for maintaining and improving GMP standards and I am very pleased to be involved in this training and development opportunity.
MQA Solutions will be supporting a Pharmig webinar on Water quality as a follow up to the recent one day training event. Unfortunately I was unable to attend and hence the course content will be delivered via Webinar.
Finally in this update I can confirm I will be attending the DBA Alumni event on 6/7 June. It is a great opportunity to update on technical and regulatory changes and of course to network, so I hope to see some of you there.

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.