Jahanvi (Janie) Miller, PDA | May 30, 2017
Whenever I hear industry experts citing a PDA technical report, it provides insight into the value of these documents that can be
shared with technical report teams, other volunteers, and staff. At the Parenteral Packaging conference in March, amid discussions about
regulatory updates, inspection findings, primary packaging challenges, and container closure integrity issues, speakers often referenced
Technical Report No. 76: Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral
Packaging. Apparently, organizations are using this document to better classify their nonconformities. This technical report was published
in October, and six months later it’s still gaining traction as a topic of discussion.
An annex to TR-76 is currently under development. The annex will focus entirely on identifying nonconformities specific to prefilled
syringes and will complement some of the existing information in Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology
Applications. As far as other packaging-related technical reports, a team is looking to revise or, potentially add an Annex to
Technical Report No. 27: Pharmaceutical Package Integrity—a document last published in 1998! The team working on this revision expects
to send a draft out for peer review toward the end of this year. Interestingly, the team has already expanded part of the document in
response to the revision of USP General Chapter <1207> Sterile Product Packaging–Integrity Evaluation. In addition, the document will
address new technologies and the application of risk-based approaches.
As you can see, we continue to add to our library of technical reports on packaging topics. If you’re interested in working on a technical
report team for such a document in the future, I recommend getting involved with our Packaging Science Interest Group. The leadership
team supporting this group is very high energy with a wide range of expertise across multiple areas of packaging science. Derek Duncan,
the EU head of the interest group, facilitated an in-depth discussion on the latest in packaging at the group’s first meeting of 2017,
held during the Packaging Conference. Based on this, and the group’s dynamic leadership team, we anticipate more lively interaction and
member support from this interest group.
If you would like to take part in future discussions, please visit the interest group’s PDA ConnectSM page.