Featured Pharma Online Editorial

  1. How To Prepare For An FDA Inspection
    7/29/2019

    An FDA inspection is very different than an ISO certification or surveillance audit — too often, organizations “prepare” for scheduled ISO audits by playing catch-up on activities that have been neglected or otherwise overlooked. The catch-up strategy will be problematic for FDA inspections and will generally result in inspectional observations.

  2. 3 Surefire Approaches To SOP Harmonization
    7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  3. 4 Trends In Recent FDA Warning Letters To OTC Drugmakers — And How To Avoid Them
    7/19/2019

    A recent flurry of warning letters issued to manufacturers of over-the-counter (OTC) drug and health products has revealed similar deficiencies related to current good manufacturing practice (GMP) and quality management expectations.

  4. 4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
    7/17/2019

    Bias can take many forms and is often not easily recognized by an investigator. Sherlock Holmes was keenly aware of bias' potential impacts. Applying more of Holmes’ famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.

  5. How Sherlock Holmes Improved My Microbiological Root Cause Analyses
    7/3/2019

    This two-part article contains a collection of some of the most famous quotes attributed to Holmes that can be applied to microbial root cause analyses (RCAs). Keeping them in mind when conducting your analyses can greatly increase your chances of success in identifying that elusive definitive root cause.

  6. AI, Data Integrity, & The Pharma Industry: Let’s Not Wait Until Someone Dies
    6/18/2019

    Simply performing computer system validation or managing computer systems under CGMP conditions is not enough to ensure data integrity and data quality for data sets where AI/ML is intended to be applied.

  7. How To Develop Optimal Pharmaceutical Quality Control Strategies
    6/14/2019

    How can pharma product quality improve? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance.

  8. An Analysis Of 2018 FDA Warning Letters Citing Data Integrity Failures
    6/12/2019

    FDA enforcement for failures in data integrity and data governance began almost 20 years ago, and these areas remain as enforcement initiatives of the FDA and other global health authorities to this day.

  9. 7 Tools For Breakthrough Quality And Performance In 30 Days
    6/7/2019

    In this sixth installment on the selection and use of quality improvement tools in your organization, Ben Locwin wraps up the series with a treatise on the 7 Tools of Quality.

  10. Essential Points To Consider For Better Microbial Data Deviation Investigations
    6/3/2019

    Microbial data deviation investigations are notoriously difficult to perform. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial.