Quality Featured Articles

31. Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity 8/18/2021

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

32. What To Expect From A Remote Inspection -- & How To Navigate It 7/23/2021

    Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.

33. FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities 5/3/2021

    On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

34. Applications For High Voltage Leak Detection You Might Not Be Aware Of 4/27/2021

    Learn in detail about High Voltage Leak Detection (HVLD), packaging applications that can be inspected with HVLD, and how to determine the best leak-testing method for your application.

35. 6 Reasons To Consider HVLD vs. Vacuum Decay For Pharma Products 4/19/2021

    Here, we compare two of the more common methods for container closure integrity testing: high voltage leak detection (HVLD) and vacuum decay.

36. Can Wearable Devices Bridge The Gap Between Pen Injector And Pump? 4/8/2021

    There is a convergence of trends in the drug delivery market toward a demand for innovative device solutions to reliably administer medicine, monitor compliance, and improve patient quality of life.

37. FDA Inspections: Are Changes On The Horizon? 4/2/2021

    A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.

38. Establishing An Effective Calibration Program 3/15/2021

    Calibration is the comparison of inspection, measuring, and test equipment against a traceable reference device to determine if accuracy and precision limits are met. It is one of the fundamental, yet often neglected requirements for GMP. Several international standards, regulations, and guidances provide requirements for an effective calibration program.

39. Gas Ingress Methods As Replacement Of Blue Dye Ingress Testing For Container Closure Integrity 3/10/2021

    This article describes the headspace gas ingress testing approach which is increasingly being implemented to replace blue dye ingress as a general CCI test method.

40. Helium Leak Detection Solves Cold Supply Chain Challenges 3/3/2021

    Vaccines and other large-molecule products require unique cold chain storage conditions. Helium detection technology can improve the quality of drug delivery system and container design.