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The News in Depth

Data Integrity Guidance Revisions by FDA and PIC/S Deepen Industry’s DI Resource Pool

Updated guidances from FDA and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on maintaining data integrity (DI) across the product lifecycle have deepened the pool of resources that industry now has available to support its DI efforts.

IPQ Monthly Update – February 2019 in Review

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.

Cell and Gene Therapy Initiatives Prominent on Biomanufacturing Agenda of U.S. National Institute of Standards and Technology

The growing need for standards in the rapidly evolving world of biopharmaceuticals and cell and gene therapies (CGTs) is giving rise to an expanding array of collaborative initiatives, products, and processes, many of which are flowing through the U.S. National Institute of Standards and Technology (NIST).

FDA’s Focus Has Sharpened on Water Systems in the Wake of Nonsterile Product Microbial Contamination

FDA has been sharpening its focus on water systems during inspections of nonsterile liquid products as microbial contamination problems of significance in these products continue to surface.

IPQ Monthly Update – January 2019 in Review

The January 2019 issue explores: ● the mission, process, and rapidly expanding project portfolio of the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) ● the significant efforts of the Gates Foundation, and its newly formed, biotech product-oriented Gates Medical Research Institute, to support CMC innovation that will increase developing world medicines access ● the issues that pharmacopoeial and registration divergences create globally, and the pathways for addressing them, and ● what it takes for biotech companies to avoid GMP compliance problems that can jeopardize application approvals and create manufacturing pitfalls.

Pharmacopoeia/Industry/Agency Global Dialogue on Compendial Compliance and Harmonization Continues, with Medicine Availability at Stake

Industry, regulatory authorities and pharmacopoeias continue to explore ways to address the difficult challenges of complying with and harmonizing compendial and regulatory requirements in the effort to ensure and enhance the availability of medicines around the world.

FDA Investigators Will Focus on Simple GMP Lapses when Inspecting Complex Biotech Systems, Former Compliance Official Cosgrove is Advising

Former FDA Center for Drug Evaluation and Research (CDER) senior compliance official Tom Cosgrove, now a partner at the law firm Covington & Burling, is cautioning biotech companies to make sure they are in compliance with the more mundane GMP details, on which investigators will be focused, to keep the regulatory pathway clear for their […]

IPQ Monthly Update – December 2018 in Review

The December issue provides updates on FDA/CDER’s Office of Generics Drugs and Office of Pharmaceutical Quality – what have been the key areas of focus over the past year and what the top priorities are going forward. The third story crosses the Atlantic to explore how Brexit is impacting the MHRA in the medicines arena and what the agency is doing to prepare for what may happen.

Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving

The Bill & Melinda Gates Foundation is stepping up its commitment to helping solve the complex chemistry, manufacturing and control (CMC), regulatory, financial, and distribution challenges of providing quality medicines for developing countries.

CDER’s Office of Pharmaceutical Quality is Opening New Regulatory Pathways to Span Its Broad Responsibilities and Global Reach

The “strategic priorities” of the Office of Pharmaceutical Quality (OPQ) for the next few years speak to the breadth and global reach of its regulatory responsibilities, and to OPQ’s willingness to open new pathways to fulfill them.
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