21 CFR 820 - 820.75 process validation
Original text
Expert opinion
(a) Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented.
When the products of a manufacturing step or process cannot be inspected or tested 100%, process validation must be conducted. Process validation is the second best approach to assure consistent quality and meeting specifications of manufacturing products. The procedures for process validation must be implemented in writing and the validation activities and their results documented. Documentation must follow Good Documentation Practice (GDP) and must be in compliance with document controls as per 21 CFR 820.40.
(b) Each manufacturer shall establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met.
(1) Each manufacturer shall ensure that validated processes are performed by qualified individual(s).
(2) For validated processes, the monitoring and control methods and data, the date performed, and, where appropriate, the individual(s) performing the process or the major equipment used shall be documented.
(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
Validated processes need to be controlled by means of critical parameters. These ciritcal parameters are often derived risk-based and stated in the control strategy as well as monitored in track & trace over time.
Process validation are to be carried out by qualified individuals. “Qualified” in this term is understood to be trained and skilled in the art.
Documentation of the process validation should include all data to enable an identification of what, when, how and by whom a process validation has been carried out.
(c) When changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate. These activities shall be documented.
When validated processes yield deviations, it stems from different potential error sources. To outrule systemic errors, review and evaluation of such deviations must be conducted and the decision documented whether to re-validate the process or not. Often, this continuous review and evaluation is called “continuous validation”.
