There are three keys areas to be reviewed relative to pending changes in the USP for container and package systems. Each of the three is in a different stage of the USP approval and acceptance process, but all three can have, at some point in the future, a financial and time impact on the manufacture and approval of an FDA regulated product.
The Good – USP <1207> Sterile Product Packaging – Integrity Evaluation
As published in the most recent Pharmacopeia Forum (PF), the new General Chapter <1207> is now publically available for review and comment. The chapter has been presented in four separate parts with each section reviewing a distinct area of testing. The <1207> section provides the overview and background while <1207.1> outlines test method selection, <1207.2> reviews leak testing technologies now available and <1207.3> highlights various test methods. In addition to the proposed chapter revision, the PF has published a stimuli article. The stimuli article discusses the historical perspective of package leak testing and provides fact based research data that supports the proposed improvements in the area of leak testing. To best understand and form a perspective on these changes, it is suggested that the stimuli article be read prior to the chapter sections as “background information is meant to provide perspective on the capabilities and applications of such tests, and thereby allow for a more insightful review of the proposed general chapters.”
The <1207> chapter as published in the PF represents GOOD work on the part of the USP and the committee members should be applauded for the science based diligence that they collectively applied to this difficult process. The field of container integrity testing (CCIT) will be vastly improved once these changes become effective as an easy to understand, in terms of requirements and effectiveness, has been clearly outlined. However, there still remains a “call to action” and it is imperative that key industry companies and personnel take the time to review and comment on the chapter. The comment deadline is November 30, 2014. Please visit the USP website and access the free online PF to review and comment.
The Bad – USP <671> Container Performance Testing
A revised USP General Chapter <671> will officially go into effect on December 1, 2014. While the basic tenets of the current <671> chapter are still included with no wholesale changes to the specific test steps, an entire new section has been added with the intent of better classifying container and package systems in a more precise manner. A good portion of the updated testing requirements are based upon the ASTM D7709 procedure and thus it is effective at distinguishing between low and high barrier water permeation materials in a more precise manner. However, there are two key flaws with the chapter. First, it is not clear when the more precise barrier testing permeation is required. As stated in the introduction section “test methods provided to measure moisture vapor transmission rates MAY be useful…to determine the level of barrier protection provided by package systems.” The simple key word of “may” lends one to think that this testing is optional – in fact it may be optional but more direction is clearly needed. Second, once this testing is performed, the USP does not provide any specification that enable a defined meets or does not meet determination. While the actual test procedure does offer insightful and precise data, is it to be used for informational purposes only? Changes and improvements in qualification test procedures are an ongoing event and should be applauded. However, in this specific instance, industry needs more defined guidelines on how the new USP 671 chapter should be interpreted….i.e. be on the lookout for an update from Whitehouse Laboratories prior to December 1st.
The Ugly – USP <661> Containers – Plastics
This is a “call to action” for industry. Let’s start with the history of these revisions. A proposed new USP <661> chapter appeared in the PF of September-October 2013. Based upon feedback from that original publication, a revised chapter is now being proposed. Similar to the USP <671> chapter just reviewed, the <661> chapter is confusing and hard to follow. It is not clearly defined exactly what testing is to be performed and to what extent. At a USP meeting in December 2013 set up to review only this chapter, there were mixed views and interpretations as to what the actual requirements are. The chapter is further complicated with references to two new guideline chapters that are scheduled to appear in the December 2014 PF. Having spent the past year in review and discussion of the chapter, it may best be described as confusing and if it were to become official, it will have a major financial and time to market impact on the product approval process. Comments for the current revision are being accepted by the USP until November 30, 2014. It is imperative that you invest the time and energy to review and comment. Test procedure are in constant need of review and improvement, but as experienced with the new <1207> chapter, improvements should be based upon good science, coincide with technology based advancements and should prove to be better at protecting the end user. Revisions that do not clearly meet these objectives should be avoided. Take the time to voice your opinion.