pharma from the editor

  1. Developing Optimal Pharmaceutical Quality Control Strategies
    6/14/2019

    How can the industry improve the quality of its products? The first tactic could be for the industry to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.

  2. 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. In 2018, however, we may have turned a corner.

  3. Use These 7 Tools For Breakthrough Quality And Performance In 30 Days
    6/7/2019

    Welcome to the sixth and final installment of this series on the proper selection and use of tools to help you improve Quality within your organization. This article ties together the previous five in this series with a treatise on the 7 Tools of Quality.

  4. Equipment Change Control For GMP Production Facilities — How To Start
    6/5/2019

    While many may conceptually understand change control for equipment and facilities, most lack the knowledge to apply this control to highly sophisticated equipment and the utilities to which they connect.

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

    Microbial data deviation investigations are notoriously difficult to perform. They are time consuming and labor intensive. Determining the definitive root cause is often challenging. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty.

  6. Is Continuous Manufacturing Right For Your Drug?
    5/30/2019

    Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.

  7. Could Microbiome-Based Therapies Upend The Asthma And COPD Markets?
    5/28/2019

    Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets. 

  8. “Work Harder” — And Other Ways To Completely Miss The Mark On Quality
    5/24/2019

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

  9. Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
    5/21/2019

    BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting. 

  10. 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
    5/14/2019

    It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets.