GUEST COLUMNISTS

• Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?

  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.

• A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity

  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.

• Comparing The Top 10 Pharma Inspection Findings From FDA, MHRA, & Russia’s Ministry Of Health

  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.

• Are You Prepared For The U.S. Enhanced Drug Distribution Security (EDDS) Requirements?

  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.

• A Quality Agreement Primer: Managing Risk When Working With Contractors

  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.

• Overcoming The Challenges Of Patient-Centric Specification Setting

  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.

• Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery

  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.

• ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices

  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.