Quality Featured Articles

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Why It's Vital To Choose The Right Inspection Technology For Different Drug Products 2/3/2021

    With patient safety and product quality as top priorities, the need for efficient, technologically advanced and highly accurate automatic inspection systems is greater than ever. Explore the advancements in inspection machines and case studies on turbid vaccine suspension, lyophilized drugs and biotech products.

  9. A New Way Of Looking At De-Nesting And Re-Nesting Solutions 2/3/2021

    Systems that process drug containers must prioritize container integrity and gentle handling to prevent breakages and product losses. We have developed the innovative, automatic handling unit Nestor to process ready-to-use containers, such as syringes, to and from nests and tubs.

  10. Unlocking The Power Of Artificial Intelligence For Pharma Inspection 1/20/2021

    Rapid progress is being made using artificial intelligence (AI) in visual inspection in the pharmaceutical manufacturing process. Ensuring that glass vials, syringes and other primary containers are free of splinters, particles and other defects is crucial – but traditionally, in automated equipment there has been a trade-off between detection rate and false rejection rate (FRR). AI is proving to be a game changer when it comes to this delicate balance.