Featured Pharma Online Editorial

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products
    1/18/2019

    Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.

  8. How To Establish Growth Promotion Tests For Pharmaceutical Culture Media
    1/7/2019

    The article discusses some of the guidance documents and regulatory expectations regarding media growth promotion and provides guidance on establishing a compliant growth promotion test.

  9. Does Quality Even Matter? 10 Things Quality Departments Should Stop Doing
    12/13/2018

    Senior quality leaders and the FDA agree quality organizations supporting pharma manufacturing often fall short of providing the support necessary to maintain and increase regulatory compliance and product quality. At the same time, some do not understand their actions and believe they are obstructionist and reflective of a strict compliance mentality with little regard for the business and its success.

  10. 4 Ways To Prevent Manufacture And Distribution Of Substandard Medications
    12/12/2018

    If a legitimate product is not manufactured according to quality standards or becomes degraded as it travels through its supply chain, it can be ineffective at best or deadly at worst.