Featured Pharma Online Editorial

  1. ISO 22519: An Unnecessary, Faulty, And Confusing Standard
    10/11/2019

    The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

  2. FY2018 FDA Drug Inspection Observations And Trends
    10/7/2019

    The FDA recently published GMP drug inspection data from CDER that addresses drug inspections conducted during the agency's 2018 fiscal year. This article examines the FY2018 data and evaluate six years’ worth of trends in FDA GMP inspection enforcement.

  3. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data
    9/18/2019

    This article explores some of the typical issues that may be encountered during recovery studies, and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies. 

  4. Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again
    9/12/2019

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Risk Assessment Of Objectionable Microorganisms In Nonsterile Pharmaceuticals
    4/19/2019

    This is Part 2 of a two-part article on objectionable microorganisms in the nonsterile microbiology industry It discusses a risk-based approach to determine if a microorganism is objectionable for an application.

  10. Regulatory Expectations For Objectionable Microorganisms In Nonsterile Pharmaceuticals
    4/5/2019

    This article explains what an objectionable microorganism is and explores the regulatory expectations for objectionable microorganisms in nonsterile products.