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The News in Depth

MHRA Inspectors are Advocating Data Mapping as a Key First Step on the Data Integrity Pilgrimage

Data process mapping is being strongly encouraged by inspectors from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a first step in planning, establishing, and maintaining the controls necessary to secure data integrity.

IPQ Monthly Update – March/April 2019 in Review

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.

Data Integrity Compliance Experts Are Urging Industry to Apply Regulator Perspective and Learnings in Refining Data Systems and Auditing

Data integrity (DI) regulatory compliance experts are observing that industry in-house and third-party auditors are often not detecting failures because they are not viewing the systems and processes in the same manner as agency inspectors.

The Role of Quality Culture in Data Integrity Is Getting More Attention as Regulator and Industry DI Guidances Evolve

The importance of quality culture is finding more clear expression in the refinement of regulator and industry guidances that have been forthcoming recently on data integrity (DI) and what is required to assure it.

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.
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