Regulatory Articles

1. Leverage Apps To Reduce Line Changeover Time From 14 Days To 3 6/26/2025

   A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

2. The 5 Ws Of A Human Factors Strategy 3/31/2025

   A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

3. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

   Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

4. Meeting Annex 1: A Proactive Approach To Regulatory Compliance 3/4/2025

   It was imperative for a large European CMO that produces multiple biologic drugs to select the right product quality and value for each customer to comply with the August 2023 revision to the EU GMP Annex 1.

5. Sustainable Solutions For Medical Devices 1/6/2025

   Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

6. Challenges In Developing Medical Devices From Animal-Based Biomaterials In China 11/11/2024

   Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

7. Ready-To-Use Cartridges: Ensuring Compatibility For GLP-1-Based Drugs 8/27/2024

   Ready-to-use cartridges for GLP-1 applications offer safe, reliable self-administration. See how they can minimize complexities and better align with the stringent demands of modern manufacturing.

8. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

   Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

9. Performance Test According To Chapter <41> Of The USP 7/21/2023

   This operating procedure describes how to perform a repeatability and accuracy test according to Chapter <41> of the United States Pharmacopeia.

10. Eccentric Loading Test (Eccentricity) With External Test Weights 7/21/2023

    In many laboratories, weighing is a critical process. This operating procedure describes how to perform an eccentric loading test with external test weights.