ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 12.1-12.2: Document a validation policy, identify critical parameters and attributes, and validate critical operations under quality-approved protocols and reports that address deviations

What does 12.1-12.2 require?

The company's overall validation policy, intentions and approach should be documented, covering production processes, cleaning, analytical methods, in-process test procedures and computerised systems and who designs, reviews, approves and documents each stage. Critical parameters and attributes should normally be identified in development or from historical data, with the ranges needed for reproducible operation, including defining the API's critical product attributes, the process parameters that could affect critical quality attributes and the expected range for each critical parameter in routine manufacture. Validation should extend to operations critical to API quality and purity. A written protocol should state how a process will be validated, carry the review and approval of the quality unit and the other designated units, and give critical steps, acceptance criteria, the validation type (prospective, concurrent or retrospective) and the number of runs. A report cross-referencing the protocol should summarise results, discuss deviations and draw conclusions including changes needed to fix deficiencies, and any variation from the protocol should be documented and justified.