ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 19.1-19.3: Manufacture clinical trial APIs in suitable facilities with stage-appropriate GMP, an independent quality unit approving each batch, material testing, problem evaluation, investigational labelling and clean, calibrated equipment

What does 19.1-19.3 require?

Once a drug reaches the stage where its API is made for clinical trial products, the manufacturer should make it in suitable facilities with appropriate production and control procedures. Suitable GMP concepts should apply with a mechanism to approve each batch, and a quality unit independent of production should approve or reject each clinical batch, though some testing functions may sit in other units. Quality measures should include a testing system for raw materials, packaging, intermediates and APIs, and any process or quality problem should be assessed. Labelling of clinical APIs should be controlled and identify the material as for investigational use. Throughout clinical development, including small-scale facilities or laboratories, procedures should ensure equipment is calibrated, clean and suitable, and facilities used so as to minimise contamination and cross-contamination.