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Pharmaceutical & Medical Packaging News, July/August 2015

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Page 9 of 83 • Pharmaceutical & Medical Packaging News July/August 2015 10 Industry Outlook Powers. "Now we are conduct- ing focus groups early on in development and sharing con- cept designs for feedback and then incorporating this feed- back into fi nal packaging. The key is to engage early." H o , h o w e v e r , b e l i e v e s change comes with more-com- plex products, such as those that might be considered com- bination products. "There's no question about traditional oral drugs," answered Ho. "Everyone knows how to pour liquid into a dosing cup. But when an injectable syringe (as an example of a combina- tion product) is involved, it becomes more complex. These worlds are colliding." Nonethe- less, "I don't think that we'll see disruption," said Ho. In the meantime, pharma packaging professionals are focusing on regulatory com- pliance, packaging science, and cost ef ciency. "Regulatory landscapes will force some change," Ho con- tinued. The real challenge, he said, is answering this question: "How do I comply with the regulations in each country?" Ho would like to see more external support. "To suppli- ers, I say, you need to learn regulatory requirements glob- ally. Helping you get educated helps me do what I need to do—to focus on getting drugs to market." In particular, Ho pointed to the EU's Falsifi ed Medicines Directive, which includes requirements for U.S. PHARMACOPEIA CHANGES ARE UNFOLDING Several U.S. Pharmacopeia packag- ing chapters are undergoing some sort of change, reported Dwain L. Sparks, an Eli Lilly Co. retiree and now a strate- gic advisor and expert consultant with YourEncore, to attendees at Pharmapack North America. These include the follow- ing chapters: • Chapter <381> Elastomeric Closures for Injections. • Chapter <659> Packaging and Stor- age Requirements. • Chapter <660> Containers—Glass. • Chapter <670> Auxiliary Packaging Components. • Chapter <661> Containers—Plastics. • Chapter <671> Containers—Perfor- mance Testing. • Chapter <1207> Sterile Product Package—Integrity Evaluation. • Chapter <1660> Evaluation of the Inner Surface Durability of Glass Containers. • Chapter <1663> Assessment of Extractables Associated with Pharmaceu- tical Packaging/Delivery Systems. • Chapter <1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems. "It is important for pharmaceutical packaging professionals to keep an eye on new and changing packaging standards through regulatory surveillance, especially what is transpiring with USP packaging chapters through proposals published bimonthly in the free, on-line Pharmaceuti- cal Forum," Sparks told PMP News. With all the pending revisions, it's no wonder that pharma packaging engineers are consumed with material science and performance. These engineers must understand the level of risks that prod- ucts face and how they can be addressed when developing every type of packag- ing component from plastic containers to elastomeric closures. "For instance, USP Chapter <381> on Elastomeric Closures is being restruc- tured to incorporate a risk-based assess- ment consistent with those in the recently revised USP <661>," explained Diane Paskiet, director of scientif c affairs for West Pharmaceutical Services, to the Pharmapack North America audience. She spoke during the June 9 morning session on the USP packaging chapters. "There will be future changes related to the heavy metals section; certain ele- ments will be reported as found since the limits in USP <232> Elemental Impurities only applies to f nal drug products. Appli- cants will need to verify risks based on their intended use," she said. "Limits on components alone would not be practical," she continued. "It is the applicant that will need to substantiate that cumulative elements do not exceed the total daily intake limits." For instance, "elements leached from [a] container closure system should be based on a scientif c understanding of likely inter- actions between a particular drug product type and its packaging; contributions of ele- ments from other sources such as excipi- ents will factor into the total daily intake," she said. "Studies to understand potential Percentages of 499 respondents to the PMP News 2015 Market Segment Study who purchase, recommend, specify, select, approve, or authorize the listed packaging machinery. B l i s t e r F o r m e r s S e a l e r s C o n v e y o r s V i s i on I n s pec t i on E q u i p m e n t C a r t o n e r s L a b e l e r s Pr i n t e r s What Packaging Machinery Are You Purchasing? 28% 27% 19% 18% 18% 18% 18% 17% 18% T o o l i ng F o r m - F i ll- S e a l M a c h i n e s Continued from page 7

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