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.
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.
The three stories in the Monthly Update for August explore facets of the intense discussions that are now taking place at industry/regulator forums on the CMC challenges that need to be faced en route to realizing the promise of cell and gene therapies. In focus are: ● the dialogue at the NIIMBL annual meeting on these challenges and the industry/agency/academia collaboration needed to meet them, and ● an exploration by CBER and industry experts on the added CMC pressures created for CGTs by accelerated development and review timelines and how these pressures can be dealt with.
The first story in IPQ’s Monthly Update for July explores the FDA/CDER efforts to make its quality review process more standardized, transparent, streamlined, IT rich, and knowledge management friendly through its interrelated KASA and PQ/CMC initiatives. The second story explores the attention industry and regulators are now giving to the complex web of issues that come into play in the effective use of preservatives in pharmaceuticals.
The first story in IPQ’s June issue provides an update on the effort going on in Europe to create a more transparent, effective, and uniform process for regulating the quality of drug-device combination (DDC) products and how a draft guideline issued in June is contributing to that effort. The second explores the regulatory developments in China, the implications for pharma and excipient suppliers producing products for a global market, and how IPEC is urging China to more closely align with international norms.
The May 2019 Monthly Update provides the last two in a series of four IPQ stories on the current developments and industry/regulator interactions around data integrity. Explored are: ● the regulatory/industry interactions, initiatives, and findings on the detection of DI lapses, preparing for inspections, and remediation, and ● the technical challenges of data management as the data pool grows, and the strategies MHRA and industry experts are recommending to meet them. [The March/April Monthly Update provides the first two stories in IPQ’s DI series.]
The March/April 2019 issue provides the first two in a series of four IPQ stories on the current developments and industry/regulator interactions around data integrity. Explored are: ● the revisions that FDA and PIC/S have made to their DI guidances as part of a deepening pool of resources that industry now has available to support its data governance efforts, and ● how the role of quality culture is getting more attention as the regulator and industry DI guidances evolve.
The February 2019 issue provides an in-depth review of: ● FDA’s increased focus on water systems as microbial contamination problems, particularly with B. cepacia, continue to surface around the world in non-sterile as well as sterile products and drive changes to the US and European pharmacopeias, and ● the role of the U.S. National Institute of Standards (NIST), in collaboration with a host of stakeholders, in creating a more robust standards infrastructure to support the complex development, manufacturing, and control challenges presented by rapidly evolving biotech products and processes.