Articles by Mark Durivage

  1. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.

     

  2. Remote Auditing Best Practices For GMP Compliance 3/25/2020

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  3. A SMART Approach To CAPA Effectiveness Checks 3/9/2020

    Many times, corrective and preventive action (CAPAs) fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. This article will look at using the SMART (specific, measurable, achievable, relevant, and time-bound) methodology for use in developing a CAPA verification of effectiveness plan.

  4. The 10 Phases Of An Effective CAPA 2/5/2020

    Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

  5. Packaging Good Manufacturing Practices (GMPs) For Medicinal Products 1/6/2020

    Has your primary packaging materials supplier established, implemented, and maintained an adequate quality management system? The requirements of ISO 9001 may not provide the necessary levels of GMPs and rigor to ensure the packaging materials are adequate for their intended use.

  6. Design Of Experiments 101: Understanding DOE's Foundational Elements 12/9/2019

    DOE is a very powerful tool that can be used to characterize a process. This article discusses several types of experiments, as well as the basic statistical tools and techniques, that can be used when performing a DOE.

  7. Process Characterization: The Foundation For Validation 11/18/2019

    Process validation should never be performed until the process is fully characterized. A failed process validation should be a rare event; otherwise, a Warning Letter will probably be in your future.

  8. An Introduction To Sampling Plans 10/21/2019

    Sampling plans are used extensively throughout organizations regulated by the FDA. Most have a statistical procedure that specifies a certain acceptable quality level based on risk. (If not, they should!) However, most  follow the requirements of the procedure without fully comprehending how sampling plans actually work. This is why you should.

  9. Is Your Personnel Hygiene Plan Up To Date? 8/27/2019

    Every organization that is regulated by the FDA must consider sources of contamination and cross-contamination in their manufacturing operations. A robust personnel hygiene program is an important element for good manufacturing practices (GMPs) necessary to prevent contamination and cross-contamination, in order to ensure the safety of medicinal products.

  10. How To Prepare For An FDA Inspection 7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections.