Industry Perspectives

1. Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification 7/1/2025

   A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

2. What To Expect When You Move Into Production For The First Time 6/17/2025

   In medical device development, things don’t go quite as you planned the first time around. This article shares what to really expect when you take your device into manufacturing.

3. Cleaning Process Capability: Understanding Populations, Samples, And Sample Size Requirements 6/6/2025

   This article examines the role of sample sizes in the determination of cleaning process capability or process performance in the manufacture of drugs/therapies and medical devices.

4. 3 Lesser Known Keys To Effective Biopharma Supplier Engagement 6/4/2025

   In this article, Fran DeGrazio lays out ways for biopharma companies developing and commercializing combination products and other drug delivery devices to ensure that their product requirements and related documentation needs are well met by suppliers of materials, devices, components, and services. 

5. Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis 5/6/2025

   Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

6. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

7. Struggling With GxP Systems? There's A DAP For That 4/2/2025

   A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

8. Risk Management Planning: Be Prepared When Disaster Strikes 4/1/2025

   Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

9. The Future Of Medical Device Labeling Is Here 4/1/2025

   Medical device labels that lack information or contain inaccurate information may lead to product recalls or delays in product release. Generative AI offers a solution to streamline the labeling development process. 

10. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

    Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.