The
EDQM/European Pharmacopoeia (Ph. Eur.) and the Indian Pharmacopoeia Commission
(IPC) held a symposium in Mumbai to discuss the quality control of medicines in
the context of the pharmaceutical legislation and regulatory requirements that
exist in Europe and India.
The
event was attended by authorities and manufacturers alike, in particular those
involved in the manufacture of APIs, from production, quality control and
regulatory affairs. The programme covered an overview of the roles of the EDQM/
Ph. Eur. and the IPC in the quality control of medicines including
harmonisation activities. Practical advice was also given on using and
interpreting the European Pharmacopoeia General Chapters and Monographs,
together with an overview of the policies and processes used to establish
Pharmaceutical Reference Standards.
Discussions
also covered the EDQM’s Procedure for Certification of Suitability, or CEP as
it is more commonly known.
Posted by Dr. Tim Sandle