Insights On Regulatory Compliance

31. Equipment Validation In The Pharmaceutical Industry 12/17/2024

    Equipment validation ensures pharmaceutical equipment meets regulatory and quality standards. Explore how a structured process ensures compliance, reliability, and high product quality.

32. Sterile Contract Manufacturing Selection: Aligning CGMP With Precise Product Requirements 6/30/2025

    Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

33. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

34. Navigating The Evolution Of EU Health Technology Assessment (HTA) Regulation 5/9/2025

    The future of pharmaceutical access in Europe is being shaped by the new EU HTA regulation. Insights from Pharma 2025, featuring Herbert Altmann and Alexander Natz, shed light on this pivotal shift.

35. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

36. 6 Things To Consider During Visual Inspection Operations 7/14/2025

    Even with automation, manual visual inspection remains vital in sterile drug manufacturing. Discover six advanced considerations for refining your operations, ensuring compliance, and minimizing costs.

37. How To Easily And Quickly Monitor Cleanrooms 5/6/2024

    Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.

38. Automated Validation And Centralized Data 7/23/2025

    Discover how intelligent CPV, powered by automation and real-time analytics, is transforming manufacturing by driving quality, compliance, and innovation in a rapidly evolving regulatory landscape.

39. Cleanroom Conceptual Design Paradigm: Converting Spaces For GMP Operations Part 2 6/16/2025

    Learn essential conceptual design principles for transforming alternative spaces into efficient, regulatory-aligned cleanroom environments for your critical processes.

40. Analytical Strategies For Impurity Control In Antibody-Drug Conjugates 7/16/2025

    Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.