US excipients industry group IPEC Americas issued a draft version of the “technically unavoidable particle profile (TUPP) guide” in 2013 and since then, in collaboration with IPEC Europe, it has been working to fine tune and finalise the document.
Technically-unavoidable particles are, as the name suggests, impossible to eliminate in batches of drug excipients. They are created by the manufacturing, handling and packaging methods used to produce the compounds.
The problem is that although the particles are neither associated with safety concerns nor any formulation issues, regulators view the unsightly particles – also called “black specks” in the trade – with suspicion according to IPEC Americas.
"A central cause of the increased concern is the issuance of several US FDA Form 483s to pharmaceutical companies by US FDA investigators for insufficient or incomplete investigations of unusual, visible particles.”
The organisation added that: “Previous guidance from IPEC, USP or FDA has not dealt with this issue effectively and as a result materials, and in some cases entire excipient lots, are rejected unnecessarily.
“This,” it continued “has resulted in both users and makers spending time, money and resources investigating particles that are technically unavoidable and do not pose a risk to patient safety.”
Publication
The final version of the guidelines was submitted for final review in June according to an article in IPEC Europe’s Excipient Insights newsletter.
An IPEC spokeswoman told in-Pharmatechnologist.com “the technically unavoidable particle profile guide has been finalized by both IPEC Europe and IPEC-Americas and it is available to IPEC-Americas members who are logged into the website.”
She added that: “It is anticipated that the guide will be published and an electronic version will be available to the general public prior to the end of December.”