INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue

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Pandemic Experience Showcases the Potential for Faster Innovation, More Collaboration, and Workplace and Operations Modernization

The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen.

Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts:

PART I: The Evolving Landscape of Pharmaceutical Operations

PART II: Government-Industry Collaboration in This and Future Pandemics

PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access

[Parts I and II of the story are now available to subscribers. Part III will be June 27.]

IPQ Monthly Update – March and April 2022 in Review

The two stories in IPQ’s March/April 2022 issue explore: ● the drivers for and progress in incorporating more third-party auditing of excipient suppliers into user quality management systems, and ● updates from regulator, compendial and industry experts on the CMC challenges of peptides and oligonucleotides.

Progress in Addressing Impurity Challenges in Focus at USP’s 2022 Peptide/Oligo Workshop

The progress in understanding and addressing the challenges of impurities was a key focal point of this year’s USP Therapeutic Peptides and Oligonucleotides Workshop, held virtually on February 28, March 2 and March 4, 2022.

PART I: US and European Regulator Perspective on the CMC Challenges of Oligonucleotides

PART II: USP Standards Development Efforts for Peptides and Oligos

PART III: Peptide and Oligo Analytical, Manufacturing and Raw Material Considerations

IPQ Monthly Update – January and February 2022 in Review

The two stories in IPQ’s January/February issue explore: ● FDA, industry consortium, and ICH efforts to modernize the way quality information is collected, submitted, and managed, and ● the efforts to strengthen the interface between FDA and industry around manufacturing modernization, with insights from two innovation champions, Janet Woodcock and Jeff Baker.

FDA’s KASA and Related PQ/CMC Initiatives on Improving CMC Data Structuring and Sharing Will Help Support ICH M4Q Revision

FDA’s Knowledge-aided Assessment and Structured Application (KASA) and related Product Quality/CMC (PQ/CMC) initiatives have been laying some important conceptual and information technology (IT) groundwork for the ICH effort now underway to revise its M4Q guideline on the quality component of the Common Technical Document (CTD).

Part I: The Advancing Knowledge-aided Assessment Component of KASA

Part II: Bringing Biologics into the KASA System

Part III: The Progress of FDA’s PQ/CMC Initiative

Part IV: The Goals of Accumulus Synergy in CMC Data IT and Regulatory Communication

Part V: The Drivers for Revising ICH M4Q and Evolving the CMC Regulatory Process

IPQ Monthly Update – December 2021 in Review

The two stories in IPQ’s December Monthly Update explore: ● the recent efforts of the USP and European Pharmacopeia to meet the needs of the emerging biotech product modalities and their complex analytical challenges, and ● recent developments in the European GMP arena as its regulator and industry stakeholders work with their counterparts globally to digest and deploy the experience and learnings from the pandemic.