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.
The European Pharmacopoeia Commission (Ph. Eur.) has decided to recruit international experts to ensure the compendium evolves with the globalisation of the pharma industry.
The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.
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.