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.
The European Pharmacopeia Commission has adopted a revised monograph that allows a broader range of purification methods to be used for the production of water for injectable pharmaceuticals.
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.
'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.
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 Council of Europe (CoE) has launched an online service which will allow patients to check the authenticity of their medication using just a smartphone.
in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based...
The three main international pharmacopoeias in the US, Europe and Japan are experiencing a difference of opinion on the tricky topic of testing pharmaceutical ingredients for heavy metals.
An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.
