International Pharmaceutical Quality - Weekly Supplement: Week Ending April 5, 2024

Sep 8, 2026

Weekly Supplement (week ending April 5, 2024) delivers international pharmaceutical quality and regulatory intelligence, centered on CMC and GMP developments and global harmonization needs. Highlights include current insights from MHRA leadership on sustainability and Net Zero support, a brief roundup of FDA, OPQ, TGA, HHS, EDQM, and EMA updates, plus coverage of FDA drug GMP warning letters and enforcement-driven recalls. The publication also guides readers to deeper monthly and archive resources for contextual decision making.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Inside the Global Regulatory Dialogue

Current Insights From Leading Regulators

Updates in Brief: Global CMC/GMP Developments

FDA Drug GMP Warning Letters

FDA Drug Recalls

Other IPQ Content Released During the Week

WEEKLY SUPPLEMENT: WEEK ENDING APRIL 5, 2024 IPQ INTERNATIONAL PHARMACEUTICAL QUALITY Inside the Global Regulatory Dialogue CURRENT INSIGHTS FROM LEADING REGULATORS MHRA’s Chief Partnerships Officer Explains How the Agency Is Supporting Sustainability | | At the DIA Europe Conference, held in Brussels in mid-March, MHRA Chief Partnerships Officer Glenn Wells gave an opening keynote presentation on the agency’s role in supporting sustainability and Net Zero goals. He discussed: ● British Pharmacopoeia sustainability initiatives ● UK medical device regulation provisions ● the role ofMHRA and its place in the UK system for healthcare and sustainability, and ● national and international collaboration. | | --- | --- | UPDATES IN BRIEF: GLOBAL CMC/GMP DEVELOPMENTS ● FDA Guidance on Data Integrity for In Vivo Bioavailability and Bioequivalence Studies ● FDA Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements ● OPQ 2023 Annual Report ● TGA Assessed Listed Medicines Guidelines ● TGA Updated Recall Procedure ● HHS White Paper on Preventing Drug Shortages ● EDQM March Reference Standards and Replacement Batches ● EMA Committee on Herbal Medicinal Products Activities FDA DRUG GMP WARNING LETTERS Company Betone Bodywell Natural Skin Care Facility Location Mexico Canada Product Type Finished Finished FDA DRUG RECALLS Among the five recalls posted in FDA’s enforcement report during the week, one drew the most serious, Class I, rating. It involved the presence of particulate matter in treprostinil for injection. OTHER IPQ CONTENT RELEASED DURING THE WEEK IPQ’s November/December Monthly Update contains the full five-part story on pharma’s evolution from a compliance to a risk-based control strategy orientation, along with Updates in Brief, FDA warning letters, EMA NCRs, and FDA drug recalls that were posted at [IPQ.org](IPQ.org) during the two months. [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 recen

FAQs

What regulatory dialogue topic is highlighted in the opening section for this week?

It focuses on MHRA’s support for sustainability and Net Zero goals and explains the agency’s role and collaboration within the UK and internationally.

Which types of CMC/GMP updates are included in the brief section?

The supplement summarizes guidance, annual reports, guidelines, recall procedure updates, reference standards, and committee activities from multiple regulators and organizations.

How does the supplement cover FDA enforcement actions during the week?

It lists FDA drug GMP warning letters by company and facility details, and it reports FDA drug recalls, including a Class I recall tied to particulate matter in a treprostinil injection.

Sep 8, 2026

Upload by Oliver Hayes