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  • Regulatory NewsRegulatory News

    40% of Manufacturers Fail to Connect to EU Medicines Verification System

    The nonprofit European Medicines Verification Organisation (EMVO) warns that five months into the operation of the European Medicines Verification System, which is meant to protect against falsified medicines and supply chain disruptions, a significant number of manufacturers and supply chain actors have not yet connected to the tracking system. “Current available data from EMVO/NMVOs [National Medicines Verification Organisations] estimate that two fifths (40%) of manu...
  • Regulatory NewsRegulatory News

    PhRMA, AAM Seek Tweaks to FDA’s Verification Guidance

    Pharmaceutical and generic drug industry groups are seeking changes to US Food and Drug Administration (FDA) draft guidance on the verification systems that can determine, quarantine and investigate suspect or illegitimate products. The 11-page draft, released last October, lays out how FDA recommends that trading partners submit cleared product notifications (ie. that a product is not illegitimate) and the statutory requirements for verification, including verificati...
  • RAPS' LatestRAPS' Latest

    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
  • Feature ArticlesFeature Articles

    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    • By
    This article introduces the KYSS principle to align a robust supplier management program with regulatory requirements and includes initial identification and qualification of suppliers, supplier quality agreements and both initial and ongoing supplier monitoring. Introduction Deaths, illnesses, injuries and many recalls have been attributed to fraudulent, counterfeit or adulterated components of finished pharmaceuticals and medical devices. 1 These tragic consequence...
  • Regulatory NewsRegulatory News

    EMA Finalizes Process Validation Guidance

    The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which goes into effect in November 2016, covers process validation for a host of biological active ingredients, such as recombinant proteins and recombinant polypeptides, and may be applicable to other biological products such as vaccines or plasma-derived products. Process Valid...
  • RAPS' LatestRAPS' Latest

    Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

    Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device manufacturers have to interpret broad and varying definitions within FDA’s regulations and a related guidance document on the topic. Until now, there has been no comprehensive resource to help regulatory and quality professionals, and other stakeholders navigate device validatio...
  • RAPS' LatestRAPS' Latest

    Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

    The following chapter is an excerpt taken from The Medical Device Validation Handbook . Process and Design Validation—Regulatory Concerns Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process can be validated with a high degree of assurance and approved according to established procedures, as required by 2...