Response to the Publication of USP ‹1207›: Package Integrity Evaluation-Sterile Products

Container Closures

The BioPhorum Operation Group’s (BPOG’s) Container Closure Integrity Testing (CCIT) workstream would like to congratulate the United States Pharmacopeia’s committee for its latest revision to USP chapter <1207> Package Integrity Evaluation: Sterile Products. Generally, we believe it provides a comprehensive overview of the available methods for container–closure testing and outlines many important elements for consideration in establishing a successful CCIT strategy. We first responded to the USP <1207> draft when it was released for comment in 2014. And from our perspective, some of the changes that were proposed and concerns that were raised in 2014 clearly have been addressed. We are grateful to see that.

The purpose of this letter, however, is to highlight specific areas that cause us concern as a crossindustry group. We are aware that USP’s “informational” chapters are not compulsory. As end-users of such guidances, though — and as representatives of companies that receive the scrutiny of regulators — we recognize that informational chapters often evolve in practice to establish expectations. So any lack of clarity or any bias introduced toward specific methodologies is of concern. It is in this context that we would like USP to consider our further comments here.

These concerns center on the description, perception, and treatment of probabilistic and deterministic analytical methods — specifically dye and microbial ingress methods. We would like to see our concerns considered at the earliest possible opportunity, ideally precipitating an update to USP<1207>. Read article
SEE ALSO: 4 Steps for Managing Biopharmaceutical Projects