MQA Updates
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...
MQA Updates
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...
MQA Updates
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...
MQA Updates
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....
