Good manufacturing process (GMP) guidelines in both the EU and USA require the control of starting materials used in the manufacture of medicinal products, which includes excipients.
And since 2016, European Commission (EC) guidelines on GMP have compelled manufacturing authorisation holders to assess their entire supply chains for all materials, including excipients.
But while all pharmaceutical manufacturers should now have risk assessment in place to determine the appropriate GMP required for every excipient they use, there remain questions regarding supplier qualification and how it should be implemented.
As such, and in response to their respective members, the International Pharmaceutical Excipient Council (IPEC) and the Parenteral Drug Association (PDA) have signed a memorandum of understanding to create a joint technical report on pharmaceutical excipient good manufacturing process (GMP).
“The output of this collaboration will be a Technical Report which will provide detailed, practical guidance on how drug manufactures can address the complex challenges of implementing risk assessment in this context,” an IPEC spokesperson told this publication. “The collaboration provides a breadth of inputs from the memberships of the collaboration partners.”
There are several guidance documents already published by IPEC, including a 2016 ‘how-to’ document to help manufacturers comply with the EC Guidelines, and a 2017 overview of risk assessment tools and resources available to pharma firms, published by IPEC-Americas and IPEC-Europe.
However, the Technical Report is intended to be complimentary to these existing guidance documents according to IPEC.
“Referencing the principles outlined in these IPEC Guides, the Technical Report will endeavour to extend beyond the direction provided by offering practical examples derived from best industrial practices.”
The IPEC Federation and PDA are planning to publish the Technical Report mid 2019.