GUEST COLUMNISTS

• A Brief History Of Parenteral Process Validation — How We Got Here

  Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

• Are We Adequately Assessing U.S. Pharma Supply Chain Risks?

  There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

• Key Engineering & Facility Considerations For Liposome Manufacturing

  This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.

• Top 5 Mistakes To Avoid When Measuring Overall Equipment Effectiveness

  Despite its (apparently) trivial formulation, overall equipment effectiveness (OEE) is one of the most misleading key performance indicators ever used in the manufacturing world. This article examines five common mistakes you'll want to avoid when dealing with OEE.

• 4 Preparatory Moves For A Post-COVID World

  While we don’t know how different the post-COVID world will be, we do know that pharma and medtech leaders are looking ahead and planning to work differently.

• Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned

  IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S. 

• A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided

  Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

• What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks

  This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.