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IPQ Inside the global regulatory dialogue

The News in Depth

US/EU MRA Implementation, US Congressional Hearings, and Industry Surveys Shed Light on Global GMP Inspection Challenges and Collaboration Opportunities

During the past decade, industry and regulators around the world have been heavily focused on addressing the daunting challenges of assuring the quality of medicines across an increasingly globalized supply chain.

International Mutual Inspection Recognition Expands with ASEAN Accrediting Philippines Using PIC/S Criteria

The FDA Philippines (FDAP) has been approved to join the regulatory agencies of Singapore, Malaysia, Indonesia, and Thailand on the Association of Southeast Asian Nations (ASEAN) Listed Inspection Services (LIS), after an extended review process that included documentary, on-site, and in-process inspection assessment.

IPQ Monthly Update – November 2019 in Review

In this issue, IPQ explores the prominent FDA and industry association initiatives that are active in the quality metrics and culture arena – how they are progressing, how they interrelate, their impact, and the learnings they are providing. The first story focuses on the initiatives taking place on the pharma side, while the second shifts to the implementation of the Center for Devices' highly relevant Case for Quality and voluntary improvement pilot programs.

CDRH Case for Quality Voluntary Improvement Pilot Collaboration Shows Impressive Results for Device Manufacturers

FDA’s Center for Devices and Radiological Health (CDRH) expects to fully implement its “Voluntary Manufacturing and Product Quality” program in 2020, following a positive experience during the pilot phase of this highly collaborative alternative to traditional agency inspections.

FDA and Industry Quality Metrics Initiatives Are Paving for Way to Manufacturing and Regulatory Advancements

Three FDA quality metrics initiatives – involving site visits, industry feedback, and academic research – are expanding the understanding of how metrics can be most effective in advancing pharmaceutical quality and culture and preventing process failures and product shortages, while streamlining regulatory oversight.

IPQ Monthly Update – September/October 2019 in Review

The issue begins with an exploration of how USP is evolving its standard setting approach for the new generation of biologic products and processes, and follows with a complementary review of the challenges in raw material and excipient use in biologics, in particular. The next two stories focus on the regulator and industry learnings, respectively, in gaining experience with the unique considerations that cell and gene therapies present in facility and operation management.

Industry Experience with Autologous Cell Therapies Underscores Need for Upfront Planning on Integrating Facility Design, Operations, and Supply Lines

Industry experience with autologous cell therapies is matching up with that of regulators in underscoring the importance of comprehensive integrated planning – encompassing internal operations and facility design as well as the complexities of the supply chain – to be able to meet future capacity needs.

The Processing and Formulation Complexities of Therapeutic Biologics Compel Heightened Focus on Excipient Needs

The processing and formulation complexities of the new generation of therapeutic biologics are compelling industry and regulators to take a hard look at the risks and requirements of the raw materials and excipients involved.

USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics

The U.S. Pharmacopeia (USP) views expanded early engagement with key stakeholders through workshops, roundtable meetings/studies, and Pharmacopeial Forum (PF) Stimuli articles as an essential component in advancing performance-based standards for biologic products.

CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs

As its experience grows with reviewing cell and gene therapy (CGT) processes, equipment and facilities, CBER is strongly recommending that firms start early in thinking about the engineering and capacity needs of a commercial facility.
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