Package Inspection Featured Articles

41. FDA Proposes Inspection Of Injectable Products For Visible Particulates 2/1/2022

    FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.

42. Vaccine Manufacturing: Harnessing Lab Deviations 9/8/2021

    For National Immunization Awareness Month, we're highlighting timely vaccine manufacturing-centric content such as this from Tunnell Consulting's Bob Johnson. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

43. How To Find & Manage Biotech Consultants Effectively 9/6/2021

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

44. What's The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively? 9/3/2021

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

45. Comparing Methods For Residual Moisture Analysis Of Lyophilized Products 8/25/2021

    This article explores the different analysis techniques that can be used to determine the residual moisture levels of freeze-dried product.

46. How To Ensure Container Closure Integrity Of Combination Drug Products 8/24/2021

    The packaging for combination products can be just as complex as the products themselves. Hence, container closure integrity testing in line with current USP <1207> guidance and regulation is critical.

47. 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.

48. 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.

49. 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.

50. 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.