Contributing Editors

  1. A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity 10/9/2020

    This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.

  2. Top 10 Inspection Findings From FDA, MHRA, Russia’s Ministry Of Health 10/7/2020

    Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.

  3. Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements? 10/5/2020

    The initial requirements of the Drug Supply Chain Security Act (DSCSA) were deliberately structured and timed to allow industry to thoughtfully design and implement the required capabilities in preparation for the pinnacle requirement, which goes into effect on Nov. 27, 2023: the implementation of Enhanced Drug Distribution Security (EDDS) capabilities.

  4. A Quality Agreement Primer: Managing Risk When Working With Contractors 10/2/2020

    This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors.

  5. Overcoming The Challenges Of Patient-Centric Specification Setting 9/30/2020

    The revolution in scientific knowledge that is bringing hope to patients with devastating diseases is also setting the stage for modernizing our approach to specifications and process control. Updating our approach to specification setting will accelerate the delivery of breakthroughs to patients.

  6. Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery 9/30/2020

    Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems. This article raises a number of points to discuss with equipment suppliers and your facility engineers to plan for and assure a successful and compliant installation.

  7. ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices 9/28/2020

    This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

  8. Hazmat Regulations: What Life Sciences Companies Need To Know 9/25/2020

    It is important for life sciences companies to understand the regulations laid out in the U.S. Department of Transportation’s 49 CFR Parts 100-185 — and their impact on package design and testing requirements, training requirements, and packaging and handling hazardous materials in bulk and non-bulk forms.

  9. Can We Eradicate Tech Transfer? 9/23/2020

    While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

  10. How To Make Your CDMO Selection An Award-Winning Event 9/23/2020

    There are many considerations when it comes to selecting a partner. Cost is always a major factor, but it’s important to also consider some of the other project requirements and how well they match the skills of any particular CMO.