• 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

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
  • Feature ArticlesFeature Articles

    Pharmaceutical Cleaning Processes

    This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification. Introduction I really like my new stainless steel dishwasher. It has lots of cool, blinking blue lights, many intriguing buttons and a variety of cycles. It also performs magic. I put dirty dishes in, add detergent, push the right buttons and voila! Dishes, glasses, knives and forks all come out clean about an hour later. Technology s...
  • Regulatory NewsRegulatory News

    FDA Offers Biomarker Qualification Case Studies

    As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers. One follows a researcher who discovers a promising biomarker of drug-induced kidney injury in rats and explores how he partnered with rese...
  • Regulatory NewsRegulatory News

    MHRA Details Common Issues in Clinical Trial Applications

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays. According to the agency, more than half of the approximately 1,000 clinical trial applications submitted each year require additional information before they can be reviewed and approved. While MHRA typically reviews clinical trial applications for ...
  • Regulatory NewsRegulatory News

    FDA, NIH Unveil Initial Framework for Biomarker Qualification

    Officials from the US Food and Drug Administration (FDA), the Foundation for the National Institutes of Health (NIH) and other stakeholders, including experts from Genentech, Merck, Pfizer and Takeda, have released a framework for proposed evidentiary criteria to support the regulatory acceptance of biomarker use in drug development programs. The framework, released 6 December, is expected to help support FDA in the development of relevant guidance(s) for evidentiary cr...
  • Feature ArticlesFeature Articles

    Process Validation Review: How Many Ways Can You Bake a Pie?

    This article explains process validation in a fun way using pie baking as an analogy. If you are like me, you cook for Thanksgiving. In my family, I am expected to make several pies and my favorite is Kentucky Pie, a cross between chocolate chip and pecan pie—yummy! Every year, it turns out different. Some years, I make it with bourbon, some without and sometimes with cornmeal instead of flour. Each time it is pretty good, but different because I like to be creative. W...
  • Regulatory NewsRegulatory News

    Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials

    The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD). According to the PKD Foundation , ADPKD is the fourth leading cause of kidney failure, and more than 50% of people with ADPKD will develop kidney failure by age 50. And accord...
  • Feature ArticlesFeature Articles

    The New KYSS Principle: Know Your Supplier's Supplier

    • 27 May 2016
    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...
  • Regulatory NewsRegulatory News

    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...