Contributing Editors

  1. Automating Compliance Operations Using Motor, Sensor, & Decider Bots

    Life sciences businesses need to move quickly and innovate. Compliance is often seen as a brake that slows businesses down, and in some cases it may become a barrier to innovation.

  2. 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.

  3. 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.

  4. 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.

  5. Are You Prepared For The Upcoming USP <800> Requirements?

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.

  6. 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.

  7. FDA's New Quality Agreement Guidance: What It Says (And What It Fails To Say)

    FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.

  8. 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.

  9. 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.

  10. 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.