INSIGHTS ON REGULATORY COMPLIANCE

• The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators

  Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.

• The Benefits Of Low Endotoxin Products

  Minimizing endotoxin contamination is vital in pharmaceutical manufacturing to protect patients from harmful reactions. Learn more about rigorously tested, low-endotoxin products designed for critical cleanroom and sterile applications.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• What Drug Manufacturers Should Know About Operational Readiness

  Moving beyond last-minute checklists, true Operational Readiness is about intentionally building success into your facility’s DNA. Discover the foundational elements that enable a smoother and safer startup.

• Regulatory Compliance And Audits For Parenteral Manufacturing Precision

  6/30/2025

  CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

• Unlocking Digital Transformation: Embrace CSA For Rapid Innovation

  7/16/2025

  Gain valuable insights from industry leaders on how life sciences manufacturers can embrace innovation and digital transformation through the FDA’s CSA guidance.

• Testing Cell-Based Immunotherapeutics For Microbial Contaminants

  10/23/2023

  In this study, two different immune cell preparations were evaluated for their compatibility with the Milliflex® Rapid System to establish a USP and EP compliant method for rapid sterility testing.

• 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.

• Your Environmental Monitoring Can't Be Your Only Line Of Defense

  9/1/2025

  Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.