guest columns

  1. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)

    This article explains the critical components of a compliant disinfectant efficacy testing package in the U.S.,  along with tips for assembling the package.

  2. How To Ace Your FDA IND Submission (And How To Rebound If You Don’t)

    Whether you read Part 1 of this three-part series — and sought pre-IND (Investigational New Drug) feedback from the FDA — or not, let's assume you have your pre-IND ducks in a row. Now you're ready to embark on preparing and submitting the IND application to the FDA, which, if approved, will allow you to test your drug in humans for the first time.

  3. What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  4. The Small Pharma–CDMO Marriage: How We Can Make It Even Better

    Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.

  5. Examining FDA’s New Quality Agreement Guidance

    The new FDA guidance is a simple one, providing best practices and high-level insight into the components of a quality agreement. This article continues the discussion from Part 1, analyzing the elements that the agency indicates should be included in quality agreements — and explaining how FDA missed a chance to truly provide value to the industry.

  6. Why Training For Compliance Doesn’t Work (And What Does)

    Training based first and foremost upon compliance does not adequately prepare people to handle the unexpected, because this mode of training does not emphasize what should always be of paramount importance to technical employees: asking scientific questions.

  7. Supply Chain Risk Where You Least Expect It — Good Supply Practices For The Life Sciences

    The medtech, pharma, and biotech industries are concerned about their inability to consistently ensure the supply of incoming materials. This article offers recommendations for good supply practices - assembled by a team of FDA officials and industry professionals - that reduces the risk to finished product quality, patient safety, and business success.

  8. How To Establish The Number Of Runs Required For Process Validation

    FDA regulations, ISO standards, and GHTF guidance documents do not prescribe the number of runs required for process validation activities. Industry has typically used three batches during the process performance qualification phase to demonstrate that a process is capable of consistently delivering quality product, but the so-called "rule of three" is no longer appropriate for process validation activities.

  9. 9 Steps To Successfully Embed Quality Personnel On The Shop Floor (And Why It’s Important)

    It is a regulatory requirement to have a quality unit in place to oversee all aspects of a manufacturing organization.  But how that quality unit should be rolled out is open to interpretation, and each approach has its own strengths and weaknesses.

  10. Is GMP Quality System Auditing Fundamentally Flawed? — A Data Integrity Alternative

    Pharmaceutical inspection approaches rely on the evaluation of several or all components of the quality system: quality, production, laboratory, materials, facilities and equipment, and packaging and labeling.  One area where it has serious limitations, however, is in the assessment of data management and data integrity.