Contributing Editors

  1. U.S. DoD Opens Advanced Biologics Manufacturing Facility For Private, Public Use

    The U.S. Department of Defense recently opened the Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) facility — the first dedicated advanced manufacturing facility capable of developing and making biological (and small-molecule) products to protect service members who may be exposed to biological weapons or natural threats. 

  2. An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

  3. 4 Major Trends In Pharmaceutical Packaging

    There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

  4. Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

  5. CAPA Effectiveness Checks 101: How To Verify That Your Actions Plans Are Successful

    Verifying the effectiveness of a CAPA closes the loop between identifying a problem and completing the actions to solve a problem. This article explains how to choose an appropriate measurement for CAPA effectiveness checks, what methods to use, and when to perform them.

  6. The Migraine Known As The Supplier Audit — And Some Simple Remedies

    This article reviews the current regulatory expectations for the qualification of suppliers through the use of both on-site and paper audits — and provides best practices for conducting the various stages of a supplier audit, from writing supplier qualification procedures to preparing a final audit report.

  7. Trump/GOP Plans For Obamacare, Medicare, & Medicaid Have Far-Reaching Pharma Effects

    An ideology-driven rush to undo decades of healthcare policy — and the uncertainty this will create — presents real hazards for every segment of the U.S. healthcare system, including the pharmaceutical industry.

  8. How To Establish Sample Sizes For Process Validation Using LTPD Sampling

    The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.

  9. 21st Century Cures & FDA Implementation: 5 Important Takeaways For Biopharma Companies

    Now that the 21st Century Cures bill has been signed into law — following a nearly three- year journey that included a fair number of detours and roadblocks — all eyes in the drug development world are shifting to FDA.  To the question “What now?”  FDA can answer: A great deal of work.

  10. Pharmaceutical Ultrapure Water Systems: Valuable Lessons Learned From Other Industries

    In August 2002, the U.S. Food and Drug Administration (FDA) embarked on an initiative entitled Pharmaceutical CGMPs for the 21st Century ― A Risk-Based Approach.1 This initiative particularly emphasized the FDA’s recommendations regarding use of technological advances in pharmaceutical manufacturing, as well as implementation of modern risk management and quality system tools and concepts. The FDA’s continuous striving towards the goals outlined in this initiative resulted in the issuance of a number of guidances that provide industry with better tools towards modernization. These include guidance documents on process analytical technology (PAT)2 and process validation3.