Change control. The process of assuring that a computerized system remains validated following a change. It includes assessing the impact of the change to determine when and if repetition of a validation or verification process or specific portion of it is necessary and performing appropriate activities to ensure the system remains in a validated state.
A formal change control system should be established to evaluate all changes that may affect the production and quality control. Written procedures should provide for the identification, documentation, appropriate review, and approval of changes in raw materials, specifications, analytical methods, facilities, support systems, equipment (including computer hardware), processing steps, labeling and packaging materials, and computer software.
Any proposals for GMP relevant changes should be drafted, reviewed, and approved by the appropriate organizational units, and reviewed and approved by the quality unit(s).
The potential impact of the proposed change on the quality should be evaluated. A classification procedure may help in determining the level of testing, validation, and documentation needed to justify changes to a validated process.
Changes can be classified (e.g. as minor or major) depending on the nature and extent of the changes, and the effects these changes may impact on the process. Scientific judgment should determine what additional testing and validation studies are appropriate to justify a change in a validated process. When implementing approved changes, measures should be taken to ensure that all documents affected by the changes are revised.
After the change has been implemented, there should be an evaluation of the first batches produced or tested under the change.
The potential for critical changes to affect established retest or expiry dates should be evaluated. If necessary, product samples produced by the modified process can be placed on an accelerated stability program and/or can be added to the stability monitoring program.