Package Inspection Featured Articles

31. High Voltage Leak Detection For Parenteral Drug Container Closure Integrity 2/25/2023

    Medical and pharmaceutical products are often packaged in fluid-filled containers. Learn about CCIT using high voltage leak detection (HVLD), how HVLD technology works, and more.

32. Trends In FDA FY2022 Inspection-Based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.

33. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.

34. What's Behind The ASTM E3263 Standard Revision? 1/17/2023

    ASTM has published the revision of ASTM E3263 Standard Practice For Qualification Of Visual Inspection Of Pharmaceutical Manufacturing Equipment And Medical Devices For Residues. This article, written by the ASTM revision team, explains the reasons behind the revision and delves into the key updates.

35. Strategies For Developing And Manufacturing Highly Potent Compounds 1/4/2023

    Explore why it is important to classify HPAPIs, how they are evaluated, how HPAPI facilities are qualified, and strategies to ensure containment and safety when handling HPAPIs.

36. Optimizing Package Integrity Operations For Multiproduct CDMO Facilities 12/5/2022

    How can a CDMO optimize operations in a multiproduct facility while also ensuring their package integrity testing technology can meet the needs of pharma manufacturers and their products?

37. Frequent Deficiencies In GMP Inspections, Part 1 11/14/2022

    It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.

38. How CDMOs Can Avoid Package Integrity Recalls Through Sustainable Compliance 9/6/2022

    CDMOs can help drive sustainable compliance for their customers by understanding what questions they should ask to identify the right container closure integrity testing method for their customers’ products.

39. What CDMOs Should Know About Container Closure Integrity Testing 8/30/2022

    What do CDMOs need to know about container closure integrity testing and the solutions available that will help protect products and drive quality?

40. Factory/Site Acceptance Testing & Commissioning Responsibilities 2/22/2022

    Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.