Contributing Editors

41. COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals 10/19/2020

    As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.

42. A Quality Agreement Primer: What To Include & Who To Assign It To 10/16/2020

    Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.

43. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

    Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

44. Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity? 10/12/2020

    Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.

45. 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.

46. 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.

47. 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.

48. 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.

49. 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.

50. 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.