Process validation programme
Article 55
1. The number of process runs for validation shall depend on the complexity of the process or on the criticality of the process change being considered. 2. A minimum of three consecutive successful production batches shall be used for prospective and concurrent validation. In situations where additional process runs are warranted to prove consistency of the process (e.g. complex active substance processes or active substance processes with prolonged completion times), this number shall be increased. 3. For retrospective validation, data from ten to thirty consecutive batches shall be examined to assess process consistency. 4. By way of derogation from paragraph 3, fewer batches can be examined for retrospective validation, if justified. 5. Critical process parameters shall be controlled and monitored during process validation studies. Process parameters unrelated to quality, such as variables controlled to minimise energy consumption or equipment use, may be excluded from the process validation. 6. Process validation shall confirm that the impurity profile for each active substance is within the specified limits. The impurity profile shall be comparable to or better than historical data and, where applicable, comparable to or better than the profile determined during process development or for batches used for pivotal clinical and toxicological studies.