Packaging & Product Protection Featured Articles
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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.
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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?
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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.
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Late-Stage Serialization Customization: A Key Differentiator For CDMO's
10/18/2022
CMOs and CPOs currently face significant challenges, including strong competition, high cost pressure, and more. Learn why being agile, flexible, and responsive is bound to pay off.
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Digital Solutions For Combatting Counterfeit Med Devices And Pharmaceuticals
9/29/2022
Learn how digital solutions and a modern ERP system can effectively combat counterfeit med devices and pharmaceuticals to improve patient safety and business performance.
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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.
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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?
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FDA Publishes Guidance For Biopharma Container And Carton Label Design
6/13/2022
The scope of this new FDA guidance includes prescription drug products marketed under an approved NDA or ANDA, prescription drugs marketed without an approved application, and biological products marketed under an approved BLA, but the principles may apply to OTC, compounded, or investigational products.
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Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems
6/7/2022
Learn how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.
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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.