pharma from the editor

  1. 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.

  2. FDA Proposes Program To Establish Voluntary Pharma Quality Standards
    4/17/2019

    The FDA’s CDER recently released draft guidance aimed at the development and recognition of voluntary consensus standards for pharmaceutical quality. In the guidance, CDER states its belief that recognition of voluntary consensus standards “will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications.”

  3. An Introduction To Centerlining For Pharmaceutical Manufacturing
    4/15/2019

    Many pharma companies struggle to strike the right balance between enough preventative maintenance and not too much corrective maintenance for manufacturing equipment, and to achieve that balance at a reasonable cost. One method known to drive the preventative/corrective ratio in favor of preventative maintenance is centerlining.

  4. Cleaning, Sanitizing, Sterilizing, Or Wishing It Away: What Are We Doing To Control Bioburden?
    4/12/2019

    Bioburden is mobile, growing, contaminating, and touching everything we do, but it can be controlled if we understand it and follow some basic concepts. This article will focus on the EU grades B, C, D, and CNC in biotech and aseptic facilities.

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

    This article is the first part of two-part article that will discuss objectionable microorganisms recovered from nonsterile products. In this part, we will explore what constitutes an objectionable microorganism, as well as the regulatory expectations for objectionable microorganisms in nonsterile products.

  6. What Should You Do After An FDA Inspection?
    3/29/2019

    The FDA inspected your firm, and one or more FDA Form 483 inspectional observations were noted by its team. This article provides guidance on how to minimize or avoid additional enforcement actions.

  7. Beyond Human Error: Are Blunt- Or Sharp-End Decisions More Important In The Life Sciences?
    3/27/2019

    Decisions made upstream in the supply chain can have enormous repercussions downstream at the bedside or in the home, where medications are administered. How do we guarantee that the big and seemingly small decisions being made with each batch manufactured will be the “right” ones when there is so much inherent variability around us?

  8. Critical Considerations In Outsourcing Nanotechnology Drugs
    3/27/2019

    If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”

  9. Chief Quality Officers: Redesigning Quality For The 21st Century
    3/27/2019

    With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.

  10. Pharma Industry Braces For A No-Deal Brexit
    3/22/2019

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.