Validation, Commissioning & Design Featured Articles

  1. FDA Proposes Program To Establish Voluntary Pharma Quality Standards
    4/17/2019

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality. In the guidance, CDER states its belief that recognition of voluntary consensus standards “will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications.”

  2. 10 Considerations For Balance Stability
    3/27/2019

    Stability of your weighing balance is paramount when it comes to collecting reliable data for project. As the old adage goes, “Anything that can go wrong will go wrong.”. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success. The purpose of this paper is to inspire thought and dialogue regarding those “not so obvious” sources of balance stability issues. Below, you may find 10 prompt questions that will hopefully guide one in resolving those pesky head-scratchers.

  3. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    3/27/2019

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  4. Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis
    2/28/2019

    When SMEs, management, and others gather to perform a risk assessment or a root cause analysis on a failure, they’re sure to achieve the desired outcome, right? Perhaps for a simple risk assessment or investigation, but success is not very likely for one that is even moderately complicated. That’s where a skilled facilitator is needed.

  5. Solving Problems More Effectively Than Sherlock Holmes: The Contradiction Matrix
    2/22/2019

    This is the fourth article in a five-part series on better investigation and problem-solving methods and principles in the life sciences. In writing this one, I’ve been thinking quite a bit about Sherlock Holmes. Not only his exquisite methods, but also flaws in the metacognition and metaphilosophy about how the fictitious detective underwent his work.

  6. Why Data Integrity Is Impossible Without A Quality Culture
    2/19/2019

    For successful establishment and sustainability of a quality culture, “the mindset and behavior... must start at the top and be emulated by individuals at all levels and in all functions within the company.”

  7. Reimagining Quality Operations In The Life Sciences
    2/13/2019

    This article examines how to achieve cross-functional ownership of quality and the efforts of the CQO team to build quality for the 21st century, including exploring the creation of formal degree programs in quality.

  8. How To Write An Effective Validation Master Plan
    2/6/2019

    A validation master plan outlines the principles involved in the qualification of a facility, defining the areas to be validated, and provides a written program for achieving and maintaining a qualified facility.

  9. Champions Against Nonsense: A Better Way To Talk (And Think) About Quality
    1/30/2019

    This is the second of three articles focusing on an effort to address what appear to be systemic issues across quality departments. This article addresses how to reframe the way we view and discuss quality, how to better engage stakeholders, and an alternate view of how quality can add value to the company.

  10. Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products
    1/18/2019

    Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.