GUEST COLUMNISTS

• Is The U.S. Ready For A Re-shored Pharma Supply Chain?

  In the first part of this two-part article, we looked at how dependent the U.S. pharmaceutical supply chain is on critical ingredients produced in China and India and the risk that could pose to the nation’s drug supply. In this article, we will examine potential solutions to mitigate those risks and ensure the nation’s drug supply is secure.

• Introduction To The ASTM E3219 Standard Guide For Derivation Of Health Based Exposure Limits (HBELs)

  The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.

• 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.