IPQ Weekly Supplement - Week Ending July 5, 2024 - International Pharmaceutical Quality Regulatory Dialogue Update

Sep 8, 2026

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.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages10

Reading Time25 min

AccessFree to download

Current Insights from Leading Regulators

EMA’s Roberto Conocchia on Revised Annex 1 Implementation

Updates in Brief: Global CMC/GMP Developments

FDA Drug GMP Warning Letters

EMA GMP Non-Compliance Reports

FDA Drug Recalls

WEEKLY SUPPLEMENT: WEEK ENDING JULY 5, 2024 IPQ INTERNATIONAL PHARMACEUTICAL QUALITY Inside the Global Regulatory Dialogue CURRENT INSIGHTS FROM LEADING REGULATORS EMA’s Roberto Conocchia Reviews International Collaborative Efforts on Implementing the Revised Annex 1 | | 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.] | | --- | --- | UPDATES IN BRIEF: GLOBAL CMC/GMP DEVELOPMENTS ● 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 READ MORE FDA DRUG GMP WARNING LETTERS Company Sun Pharmaceuticals Facility Location India Product Type Finished READ MORE EMA GMP NON-COMPLIANCE REPORTS Company Emil Pharmaceutical Terhormon Facility Location India Italy Product Type Finished API, Finished READ MORE FDA DRUG RECALLS Among the six recalls posted in FDA’s enforcement report during the week, none drew the most serious, Class I, rating. READ MORE [IPQ.org](IPQ.org) | 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’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. | | | | --- | --- | --- | | 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.
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” 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. | |
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FAQs

What is the focus of the weekly supplement?

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. It gathers regulatory intelligence from major international dialogues and forums.

Which regulatory update is highlighted in the current insights section?

EMA’s Roberto Conocchia reviews international collaborative efforts to align on implementing the revised Annex 1, including work involving EMA inspector groups and the PICS/EMA/WHO joint implementation group.

What compliance items are included for readers to review?

The supplement includes annotated listings and links to FDA drug GMP warning letters and FDA drug recalls, as well as EMA GMP non-compliance reports posted during the week/month.

Sep 8, 2026

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