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Monthly Update - January 2016

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Monthly Update - January 2016 INTERNATIONAL PHARMACEUTICAL QUALITY IPQ Inside the Global Regulatory Dialogue IPQPUBS.COM VOL. 8, NO. 1 MONTHLY UPDATE - JANUARY 2016 UNITED STATES CMC/REVIEW ● FDA’s Generics Office Overcomes Tough Challenges to Meet Year 3 GDUFA Goals, p. 4 OGD’s Uhl Reports at GPhA Fall Tech Conference ● FDA’s API DMF Assessment Timelines Improve as eCTD Use Increases and OPQ’s p. 25 New API Review Structure Takes Hold ● Starting Materials Remains a Challenging Issue for Both Regulators and Industry; p. 33 FDA DMF Assessments Show SM Gaps ● Drug Product Quality Dashboard Taking Shape at FDA in Wake of OPQ Integration p. 43 and Expanding Knowledge Base ● IPEC-Americas Continues to Urge Family Approach in Dialogue with FDA on p. 48 Improving Inactive Ingredient Database INTERNATIONAL GMP/INSPECTION ● Challenges of Implementing U.S. and Global Serialization Mandates Compel Industry p. 65 Cooperation UPDATES IN BRIEF p. 81 U.S CMC: ● CDER 2016 Guidances ● Vet Drugs ● Bioequivalence ● USP Protein Standards ● USP Packaging ● USP Plastic Packaging U.S GMP: ● Compounder Consent Decree ● Tainted Supplements ● ER Drug Shortages EUROPE CMC: ● EMA Active Substances ● EP Raman Spectroscopy INTERNATIONAL CMC: ● WHO in India ● Canada Biosimilars ● TGA Sunscreens INTERNATIONAL GMP: ● India Track/Trace ● India Inspector Training ● China Inspections ● WHO Drug Shortages ● ISO Cleanroom Standard FDA DRUG GMP WARNING LETTERS, EMA GMP NON-COMPLIANCE REPORTS, AND FDA DRUG RECALLS POSTED IN JANUARY p. 85 MONTHLY UPDATE - JANUARY 2016 INTERNATIONAL PHARMACEUTICAL QUALITY provides in-depth coverage of emerging drug, biologic and combination product CMC and GMP issues and developments with a mission of helping advance and harmonize the quality regulatory process globally. Headquartered in Washington, D.C., IPQ is read by regulatory agencies, manufacturers, suppliers, consultants, law firms, and universities around the world. IPQ tracks the industry/regulator dialogue at key international forums along with the developments, initiatives, regulations, guidances and standards in the quality regulatory arena to create a uniquely valuable resource for the intelligence gathering and knowledge management needs of the pharmaceutical community. IPQ is all-electronic, and the substantial archive at IPQpubs.com is easily searchable through keyword and From breaking news to in-depth analysis — advanced search indexes. Links to documents referenced the quality regulatory intelligence you need and cross-links to related previous IPQ coverage in the area are included, allowing readers to quickly dig as at your fingertips! deeply into an issue and its context as needed. IPQ’s “News Alerts” provide links to the first few paragraphs of the stories newly posted online. Subscribers and license holders can click through to the full stories. The “Monthly Updates” organize the stories that went online during the previous month by region (US, Europe, and international) and topic area (CMC/review and GMP/ inspection) and are an easy way for subscribers to keep up with the current critical developments impacting the quality regulatory process worldwide. Included are "Updates in Brief" on recent developments in the CMC/ GMP global arena with links to the referenced documents and to our related in-depth analysis. Also included are an annotated listing of FDA drug GMP warning letters and recalls as well as EU GMP non-compliance statements posted during the month. Editor-in-Chief Editorial Staff–US Bill Paulson Zach Yvaire [email protected] [email protected] 202-841-5027 202-997-7141 Senior Editor Tim O’Leary Jerry Chapman [email protected] We do the work so you don’t have to. [email protected] 202-841-5027 317-361-7314 Subscribe to IPQ and relax. Aaron Kozloff Editorial Assistant [email protected] Oriana Greene 240-678-4637 [email protected] IPQ takes Its readers from: 240-565-4367 Editorial Staff–Europe Nuala Calnan ● headlines to the forces driving them Sales/Marketing [email protected] Wayne Rhodes ● regulations to their underlying intent [email protected] Food/Drug Law Advisor 202-841-9470 Eve Bachrach ● puzzle pieces to their interconnection [email protected] Publications Editor 202-342-9220 ● rules to implementation pathways Charles R. Kiss ● random data to critical trends [email protected] 202-409-6708 ● the sidelines to shaping the outcome © 2016 INTERNATIONAL PHARMACEUTICAL QUALITYTM (ISSN 1937-6898) All rights reserved. IPQ Publications LLC, 3836 Fulton Avenue, Washington, ● compliance problems to proactive tools DC 20007. Content cannot be transmitted except for internal use by companies/organizations that have licenses. For copies/reprints for other ● information to strategic intelligence use, contact Wayne Rhodes (rhodes@ ipqpubs.com, 202-841-9470). MONTHLY UPDATE - JANUARY 2016 EDITOR’S NOTE ON THE ISSUE: FDA’s vision of a quality regulatory process that would be more efficient, science-based, review/inspection coherent, and process improve- ment and product supply friendly took more concrete shape during 2015. In the January Monthly Update, we explore some of the dimensions of that transformation across CDER’s Offices of Generic Drugs and Pharmaceutical Quality. While the focus of these stories is FDA-centric, the agency’s effort to put theory into practice has significant ramifications on the global regulatory stage. Bill Paulson, Editor-in-Chief The first story focuses on the generics office “State of the Union” address traditionally delivered by the OGD Director at the beginning of the GPhA Fall conference – in this case, presented by the office’s current leader Cook Uhl. She explained the significant hurdles OGD had to cross en route to successfully meeting the 2015 GDUFA mandates, how the office is transforming itself with the user fees as fuel, and how industry can help. Integral to OGD’s review process is the role of CDER’s new Office of Pharmaceutical Quality. OPQ’s responsibilities include overseeing the quality of APIs across the NDA/ANDA spectrum. The next two stories explore how the API regulatory process is evolving with OPQ at the helm. The first of the two focuses on the impact on Type II DMF reviews – the timelines and results, and where the prob- lems lie. The next story probes deeper into the issues around a particularly thorny aspect – the designation and control expectations for starting materials. Both stories offer valuable insights from the OPQ management on the agency’s expectations and how companies can help make the review process go more smoothly. We then broaden out onto the role OPQ is playing in better integrating the review and inspection processes, and cre- ating a more knowledge-rich foundation for how they function and what they focus on. On that foundation, CDER’s vision of a drug product quality dashboard is now taking shape. The dashboard will provide a comprehensive sum- mary of the current state of quality for NDAs and ANDAs for a particular drug product. Our story offers insights from the head of OPQ’s Office of Lifecycle Drug Products on how the expanding knowledge base is key to improving lifecycle management – both for companies and for the agency. The Monthly Update continues with an in-depth review of the effort in which industry and CDER are engaged to improve the agency’s inactive ingredient database (IID) – with significant implications for what is viable in drug product formulation. The story builds off a session on the IID effort at the November GPhA conference and a work- shop focused on excipients held a few weeks later at USP. At the GPhA session, two IPEC-Americas leaders reviewed the discussions that the excipient association and GPhA have been having with FDA and where industry and the agency are now focused in bringing the needed improvements to fruition. The coverage includes insights from the CDER head of the IID improvement project. The story sheds a lot of light on the challenges involved and the stakes in addressing them. Our concluding story moves into the complex web of challenges that a global drug distribution system presents in trying to identify and trace products and what regulators and industry are trying to do to deal with it. The U.S. Congress has mandated that a robust electronic serialization system for Rx medicines be fully functional within a decade of the signing of its Drug Supply Chain Security Act (DSCSA) in 2013 – with significant milestones needing to be met in the intervening years. While a decade may seem like a long time, the challenges involved are not to be underestimated, and the old adage “he who hesitates is lost” is fully applicable. “E pluribus unum” also has relevance, with industry realizing that the problems can only be solved by close cooperation between all those involved in the manufacturing and distribution process. Our story explores the dialogue that took place among a panel of experts at a GPhA conference session in November on the progress and learnings to date on the DSCSA implementation challenges and the issues that remain to be ad- dressed as industry moves into the next phase in 2017. Also receiving panel attention was the impact of the emerging serialization and traceability requirements elsewhere in the world, and the role of pilots in the U.S. and international- ly. Cognoscenti as well as relative novices in the track-and-trace arena should both find a lot to chew on in our story. WWW.IPQPUBS.COM JANUARY 2016 3 MONTHLY UPDATE - JANUARY 2016 UNITED STATES FDA’s Generics Office Overcomes Tough Challenges to Meet Year 3 GDUFA Goals, OGD’s Uhl Reports at GPhA Fall Tech Conference A significant increase in controlled correspondences, Filing Backlog Eliminated in FY 2015 easily correctable deficiencies, and information requests, along with a major reorganization, were among the tough The OGD leader noted that, during FY 2015, her office challenges that the Office of Generic Drugs (OGD) overcame eliminated the filing backlog and approved a record number to meet the Year 3 goals of the Generic Drug User Fee Act of prior approval supplements (PASs).
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