• Feature ArticlesFeature Articles

    An overview of upstream manufacturing process and process controls for biologics drug substance: A cytokine case

    This article provides an overview for writing up the biological drug substance manufacturing process and process controls. The authors provide an example for the manufacturing of biological drugs consisting of a cytokine. They cover several complex manufacturing steps and details expected to be included in Section 3.2.S.2.2 (Description of Manufacturing Process and Process Controls) of the Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Us...
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    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...
  • Regulatory NewsRegulatory News

    FDA Proposes Rule for Appealing CDRH Decisions

    The US Food and Drug Administration (FDA) on Tuesday proposed a new rule for appealing certain decisions about medical devices made by the Center for Devices and Radiological Health (CDRH). The proposed rule is in line with legislative requirements established by the Food and Drug Administration Safety and Innovation Act(FDASIA) and 21st Century Cures Act (Cures) for clarifying procedures and timeframes for appeals of "significant decisions" to CDRH. Section 517A of...
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    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...
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    Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market?

    It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare. But what most people, particularly those outside the pharmaceutical industry, don’t realize is that what’s constraining the dissemination...
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    The Path to Successful Global Regulatory Operations: Document Management Processes and Technology Challenges

    This article discusses the process and technology challenges regulatory operation organizations face as they seek to operate globally and provides recommendations for how they can begin addressing them. As pharmaceutical organizations operate on an increasingly global scale, the regulatory operations function is being asked to perform at a higher level of effectiveness. For operating in multiple countries, often in collaboration with multiple partners, the development ...
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    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...
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    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...
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    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...
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    CDRH Finalizes Appeals Process Guidance, Adding New 'Significant Decision' Category

    The US Food and Drug Administration (FDA) this week released a final version of a guidance on the Center for Devices and Radiological Health's (CDRH) appeals process. Background The 2013 passage of the Food and Drug Administration Safety and Innovation Act ( FDASIA ) instituted a new provision under Section 603 of the act intended to overhaul how FDA's medical device regulatory division, CDRH, handles appeals. Section 603 amended Section 517A of the Federal Food...
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    FDA Attitude on Off-Label Prescribing Central to Arizona Abortion Drug Access Case

    A federal court has ruled that Arizona's attempts to limit access to an abortion drug known as RU-486 (mifepristone) are unconstitutional, drawing on the US Food and Drug Administration's (FDA) authority to support its ruling. Background The case involved Arizona's attempts to restrict the use of RU-486, which is approved by FDA for use in terminating pregnancy within 49 days of the start of a woman's last menstrual period. As FDA explains on its website , the ...
  • China's FDA Announces New Administrative Review Process

    China's FDA (CFDA) issued a notice on 6 November 2013 establishing a new administrative review process to take effect as of 1 January 2014 allowing entities to appeal decisions. A requested review must allege that the specific administrative acts infringe upon the legitimate rights and interests of citizens, legal persons or other entities. The burden will be on the applicant to establish the factual and legal basis for the reconsideration of a specific administrative ...