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The News in Depth

KASA and PQ/CMC Initiatives Gain Momentum in FDA’s Effort to Strengthen Quality Review Process

The efforts of FDA’s Office of Pharmaceutical Quality (OPQ) to standardize and streamline the CMC information in applications and how it is reviewed – initially for abbreviated new drug applications (ANDAs), and eventually for NDAs, and even biological license applications (BLAs) – is beginning to take concrete form.

IPQ Monthly Update – June 2019 in Review

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 encouraging China to more closely align with international norms.

EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment

EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.

IPEC Continues to Encourage China to Align with Global Science-Based Excipient Standards

Global excipient manufacturers, working through the International Pharmaceutical Excipients Council (IPEC) Federation and IPEC-China, continue to encourage the Chinese Pharmacopeia (ChP) to propose science-based changes that would move the ChP toward better alignment with other global pharmacopeias.

IPQ Monthly Update – May 2019 in Review

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.]

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.
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