INSIGHTS ON QUALITY CONTROL

QUALITY CONTROL SOLUTIONS

  • What is dissolution testing? Why is it critical? What should you consider for your method validation? Find answers to these questions and more in this quick guide to dissolution testing.

  • PTI Inspection Systems are scientific instruments being deployed for high risk packaging applications. The environments in which these systems operate is often highly regulated with test results having a significant impact on operational decisions. The reliability and sensitivity of a CCI test method is critical to assure that correct decisions are made to maintain product quality and patient safety. If PTI’s equipment is going to test your packaging, we aim to deliver the most effective solution. Feasibility studies offer a detailed glimpse into the technological capabilities ahead of critical purchasing decisions. Feasibility studies can also act as a preliminary test method for an application. The results from feasibility or method development testing can be rolled out to the production environment for rapid validation and deployment.

  • Blue Mountain Regulatory Asset Manager (RAM) helps life sciences manufacturers standardize maintenance, calibration, and asset workflows across sites in one validated platform.

  • Bringing complex therapies to market requires seamless integration across development, manufacturing, and regulatory strategy to reduce risk, speed timelines, and ensure quality.

  • The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.