INSIGHTS ON PHARMACEUTICAL INSPECTION

• Mastering Ethylene Oxide Sterilization: Your Comprehensive Field Guide

  Whether you're refining existing protocols or developing new ones, this guide serves as a valuable resource for ensuring safe, effective, and compliant sterilization outcomes.

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation

  Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

• A Comprehensive Guide To Sampling Protocols And Robust CCI Testing

  Effective CCI testing hinges on strategic sampling and statistical rigor. Learn why 30 samples matter, how positive controls validate defect detection, and why risk assessment ensures long-term reliability.

• Visual Inspection Of Advanced Therapy Medicinal Products

  9/2/2025

  Discover how expert database systems for inspection defect management and control help cell and gene therapies meet the requirements of USP-790 to assure they are essentially free from particulate matter.

• Ensuring Integrity: Testing Viscous Biologics In Pre-Filled Syringes

  12/18/2025

  Viscous biologics in pre-filled syringes demand precise integrity testing. Discover how advanced HVLD technology detects micro-defects and ensures sterility, meeting stringent USP <1207> standards.

• Qualicaps Virtual Pharma Expo September 2025: Oral Solid Dose Manufacturing And Packaging

  9/18/2025

  Explore how a new capsule inspection system helps manufacturers overcome labor shortages, increase throughput, and maintain quality while meeting global compliance standards.

• How Software-Enabled Manual Visual Inspection Can Boost Your ROI

  7/14/2025

  Unlock hidden cost savings in pharma manufacturing. Learn how software-enabled manual visual inspection enhances efficiency, data integrity, and regulatory readiness without full automation's capital expense.

• A Holistic Approach To CCI Is A Deterministic Approach

  1/30/2026

  A modern approach to CCI blends smart design, risk‑based strategies, and deterministic testing to safeguard sterile products. Learn how lifecycle thinking and practical sampling plans strengthen quality.