The PDA TR1 report provides guidance on process controls and quality assurance in sterile compounding. This includes:
Maintaining the validated state through routine monitoring and periodic re-validation. Key Scientific Concepts pda tr1
Unlike vague regulatory text, PDA TR1 provides action levels and alert levels for viable/non-viable particles. It clarifies where to place settle plates, when to use active air samplers, and the significance of glove fingertip sampling. The PDA TR1 report provides guidance on process
Previously implied, CCS is now explicit. TR1 2023 requires a holistic CCS document linking facility design, HVAC, raw materials, personnel flow, and waste removal. when to use active air samplers