Validation, Commissioning & Design Featured Articles

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

    Quite a bit has been written about data integrity in recent years, and an embedded, effective quality culture remains a critical success factor for fully realizing strong data integrity. In recently published guidance on data integrity, the FDA goes so far as to state very directly that “it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organizational core value and employees are encouraged to identify and promptly report data integrity issues.”

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

    This is the third of three articles focusing on an effort to address what appear to be systemic issues across quality departments, informed by a multinational group comprising chief quality officers (CQOs) from pharma, device, animal health, and consumer goods companies. It will examine 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.

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

    A validation master plan (VMP) outlines the principles involved in the qualification of a facility, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility. Master plans are written to assist an organization with validation strategies or to provide control over a specific process.

  4. 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.

  5. 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.

  6. ICH Q12: Bringing Regulatory Flexibility To Post-Approval Changes
    1/16/2019

    The convergence of regulatory agencies and acceptance of ICH Q12 across multiple agencies opens up opportunities for changes with minimal supply chain disruptions.

  7. Why Now Is The Time For An Aseptic Processing Revolution
    12/27/2018

    This article is the first in a three-part series exploring the need and means to achieve improvement in aseptic processing of sterile biopharmaceutical products. Part 1 presents the current state and opportunity for improvement using innovative technology. Part 2 further discusses some of the changes in strategy that might be needed for and result from the use and improvement of technology. Part 3 presents the impact of technology changes.

  8. “The 12 Months Of Quality:” Tips For Building A Voluntary QA Culture In 2019
    12/26/2018

    Rather than 12 days of gifts, here are 12 months of suggestions to assist you in helping your organization bring its quality efforts and programs to the next level. As you think about where you want to be in 2019, consider these thoughts as strategies for building more credibility, cachet, and value around quality.

  9. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing
    12/13/2018

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.

  10. 4 Ways To Prevent Manufacture And Distribution Of Substandard Medications
    12/12/2018

    If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst.