[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-217240-en":3,"doc-seo-217240-105":31,"detail-sidebar-cat-0-en-105":97},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":21,"is_downloadable":21,"audit_status":21,"page_count":22,"language":23,"language_code":24,"site_id":25,"html_lang":24,"table_of_contents":26,"faqs":27,"seo_title":28,"seo_description":14,"update_tm":29,"read_time":30},217240,549768064778,"Felix Montgomery","https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8",8,"Research & Report","IPQ Weekly Supplement - Week Ending July 5, 2024 - International Pharmaceutical Quality Regulatory Dialogue Update","Weekly Supplement covering international pharmaceutical quality CMC and GMP developments, with emphasis on regulatory harmonization and implementation of revised guidance. Highlights include EMA’s review of international collaborative efforts to align on Annex 1 revisions, alongside brief updates covering nitrosamine acceptable intakes, inspections and certification activities, and draft pharmacopoeia monographs for comment. Includes reference listings and links to FDA GMP warning letters and recalls and EU GMP non-compliance reports, supporting actionable regulatory intelligence for global quality stakeholders.","WEEKLY SUPPLEMENT: WEEK ENDING JULY 5, 2024  \nIPQ  \nINTERNATIONAL PHARMACEUTICAL QUALITY  \nInside the Global Regulatory Dialogue  \nCURRENT INSIGHTS FROM LEADING REGULATORS  \nEMA’s Roberto Conocchia Reviews International Collaborative Efforts on Implementing the Revised Annex 1  \n\n| | At the May 2024 PDA Good Aseptic Manufacturing Conference, EMA GMP Technical Lead Roberto Conocchia reviewed the international collaborative efforts to align on implementing the Annex 1 revisions, including those of EMA’s GMDP Inspectors Working Group and the PICS/EMA/WHO Joint Implementation Working Group. [Seep. 3. Click HERE for previous Weekly Supplements.] |\n| --- | --- |\n\nUPDATES IN BRIEF: GLOBAL CMC/GMP DEVELOPMENTS  \n● TGA Legislative Reform on Quality Testing Procedures, and ‘Boundary/Combination’ Products ● EMA Update to Acceptable Intakes of Nitrosamines ● EDQM June Inspection, Certification and Reference Standard Activities ● Six Ph. Eur. Draft Monographs Open for Comment, and End to RPT ● Ph. Eur. Revised Texts on Pharmaceutical Waters  \nREAD MORE  \nFDA DRUG GMP WARNING LETTERS  \nCompany  \nSun Pharmaceuticals  \nFacility Location  \nIndia  \nProduct Type  \nFinished  \nREAD MORE  \nEMA GMP NON-COMPLIANCE REPORTS  \nCompany  \nEmil Pharmaceutical Terhormon  \nFacility Location India  \nItaly  \nProduct Type Finished API, Finished  \nREAD MORE  \nFDA DRUG RECALLS  \nAmong the six recalls posted in FDA’s enforcement report during the week, none drew the most serious, Class I, rating.  \nREAD MORE  \n[IPQ.org](IPQ.org)  \n\n| 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.\u003Cbr>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.\u003Cbr>IPQ’s “actionable intelligence” is particularly valuable for thought leaders and decision makers who need to have a deeper understanding of the issues and their context to help shape regulatory policy and develop implementation strategies. Subscriber support allows IPQ, in turn, to make an important contribution to the efforts of key non-profit associations and public service organizations engaged in addressing the increasingly complex manufacturing and regulatory challenges for medicines in the global context. |  |  |\n| --- | --- | --- |\n| IPQ is published online, and the substantial archive at [IPQ.org](IPQ.org) is easily searchable through its keyword search indexes. Links to documents referenced and cross-links to related previous IPQ coverage in the area are included, allowing readers to quickly dig as deeply into an issue and its context as needed.\u003Cbr>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.\u003Cbr>The “Monthly Updates” provide the stories that went online during the month in a print-friendly PDF format, and are an easy way for subscribers to keep up with the critical developments impacting the quality regulatory process worldwide. Included are “Updates in Brief”on recent CMC/GMP developments of note with links to the referenced documents and to our related in-depth analysis. Also included is an annotated listing of FDA drug GMP warning letters and recalls as well as EU GMP non-compliance statements posted during the month. |  | \u003Cbr>From breaking news to in-depth analysis—the quality regulatory intelligence you need at your fingertips!\u003Cbr>We do the work so you don’t have to.\u003Cbr>Subscribe to IPQ and rel","cbCaiv4WcIm8b1EF","https://ap.wps.com/l/cbCaiv4WcIm8b1EF","pdf",543436,3,1,10,"English","en",105,"# Current Insights from Leading Regulators\n## EMA’s Roberto Conocchia on Revised Annex 1 Implementation\n# Updates in Brief: Global CMC/GMP Developments\n# FDA Drug GMP Warning Letters\n# EMA GMP Non-Compliance Reports\n# FDA Drug Recalls","[{\"question\":\"What is the focus of the weekly supplement?\",\"answer\":\"The supplement provides in-depth coverage of emerging CMC and GMP issues, with a mission to help advance and harmonize the global quality regulatory process. 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