INSIGHTS ON REGULATORY COMPLIANCE

• Service Solutions Designed To Help You Gain Speed To Clinic And Market

  Discover how speed, cost, and regulatory acceptance impact drug manufacturing, as well as learn about aseptic filling challenges and how innovative services can enhance your efficiency and compliance.

• Developing A Project Management Office (PMO) At A Small Manufacturing Site

  Discover how implementing a Project Management Office transformed a small manufacturing site into a high-performing, strategic asset within a global network.

• Preparing For A Productive CDMO Audit

  Effective CDMO audits require clear agendas, thorough preparation, and strong communication to ensure compliance, minimize disruptions, and build collaborative relationships that enhance quality and regulatory confidence.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2

  12/27/2024

  Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

• FAQs On The Revised EU GMP Annex 1: Volume 3

  9/21/2025

  The EU GMP Annex 1 revision, effective August 2023, requires a detailed Contamination Control Strategy. Learn how it impacts global manufacturers, RABS use, and personnel procedures.

• What Is The Biggest Problem With Inspector Training And Qualification?

  8/25/2025

  Discover how a truly blind system eliminates bias from the human inspection process, improving data accuracy and validation of automated inspection systems.

• Control Strategies And Method Development For Nitrosamines In Peptide APIs And Drug Products

  11/26/2024

  Pharmaceutical scientists and engineers must advance robust, sensitive, and efficient nitrosamine detection and control methods to ensure regulatory compliance and safeguard public health in peptide-based drugs.