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.
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.
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 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.