Almost one in five active pharmaceutical ingredient (API) facilities inspected by the European Directorate for Quality of Medicines and Healthcare (EDQM) last year failed to meet quality standards.
Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.
'Excipient compound' monographs should be included in the European Pharmacopoeia according to IPEC, which argues they would help manufacturers and promote acceptance of the standards outside Europe.
Growing drug complexity will soon make the European pharmacopoeia’s general chapters more valuable to innovative drugmakers than individual monographs according to Pfizer quality and compendial affairs expert, Graham Cook.
Collating drug counterfeiting cases from across Europe into a central database will help law enforcement authorities catch criminals trying to flood the region with fake medicines, according to the EDQM.
Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.
The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.
Indian API manufacturers may dominate the list of companies that have had CEPs suspended this year, but that may say more about inspection policies than it does about standards outside Europe.
The European Directorate for the Quality of Medicines & HealthCare (EQDM) has begun Phase 2 of its “track & track” anti-counterfeiting strategy and is seeking manufacturer participation.
The British Pharmacopoeia 2003 is due to be available in the next
few days, and from today can be ordered online; updates have also
been released from the European equivalent.