In March, the European Commission (EC) issued guidelines on good manufacturing practices (GMP) compelling manufacturing authorization holders to assess their entire supply chains for all materials, including excipients, before March 21, 2016.
This means that drugmakers need to identify risks to the safety and stability of excipients, from their source - animal, mineral, vegetable, or synthetic - all the way through to their incorporation in the finished dose form.
Once they have performed risk assessments, authorization holders will need to document the steps they take to maintain excipient quality.
This is a considerable challenge according to IPEC Europe, which announced today that its recently-formed task force is developing a ‘how-to’ guide to help pharma firms establish the appropriate GMP for excipients before the deadline.
The guide – which IPEC Europe decided to develop after a meeting on July 1 – will “emphasise the new requirements that will come into play and detail the responsibilities of excipient manufacturers, distributors and users” according to IPEC.
IPEC Fed warning
In May IPEC Federation - the organisation that represents the regional IPEC chapters - warned that considerable effort would be needed from suppliers and their drug industry customers to make sure they comply with the regulations.
"The implementation of appropriate excipient GMPs by suppliers will require more than a year, and may be difficult to achieve for manufacturers of certain substances not typically produced as pharmaceutical excipients" IPEC Federation said.
It added that: "Incomplete assessments may jeopardize the availability of high quality excipients that have been in use for many years."
Call for input
In addition to raising awareness about the guide, IPEC Europe also called for contributions from stakeholders.
It invited interested parties to contact the IPEC Europe Secretariat. The guide is scheduled for publication in October.