SOP/Template

Equipment, Systems, and Processes Revalidation SOP

OBJECTIVE

1.1 To comply with the requirement of policy XYZ on revalidation/requalification.

1.2. To outline the procedure by which the Validation Services Department periodically evaluates the performance of previously validated facilities, equipment, systems, and processes.  This evaluation includes a periodic review of performed critical changes/repairs.  Reviews will be performed to determine the impact to the validated state of the facilities, equipment, systems, and processes.  The objective of the program is to verify that systems continue to operate within the criteria established in the original validation and according to current Company guidelines.

SCOPE

2.1 This procedure applies to previously validated facilities, equipment, systems, and processes that are used to manufacture or to support the manufacture of pharmaceutical products intended for clinical or commercial distribution at XXXXX facilities.

2.1.1 Planned and emergency changes to validated facilities, equipment, systems, and processes are documented and evaluated via the Change Control system (SOP-XXXX).

2.2 Critical changes/repairs to facilities, equipment, systems, and processes are documented in the Critical Changes/Repairs database (e.g., Maximo, EQMS).  Review of the database involves identifying the Critical Change/Repair performed by equipment name, service manager, system association, technician, ID number, work order number, or author. The database includes Changes/Repairs from Buildings 001, 002, 003, and 004.

2.2.1 The Critical Change Review (CCR) will include applicable Change Control, Preventive Maintenance Interval Evaluation, Maintenance Work Orders, and Quarterly EM Trend Report Review (where applicable).

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