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Equipment is “validated” when there is documented evidence verifying that the design, installation, operation and performance have been certified as being equal to: or better than, the specified requirements documented in the User Requirements specification (URS). This validated status must be maintained by a purpose designed Planned Preventative Maintenance Program (21 CFR Part 211.58 refers).
Compliant equipment validation can be quite simple to achieve providing the procurement stage has been thoroughly investigated and concisely documented in accordance with a company approved process (SOP). The procurement process normally starts with the production of a documented requirement or group of requirements (URS). For new builds this must be incorporated into the originating validation or project plan (VP).
For existing facilities this should take the form of a CHANGE REQUEST (CR). As soon as management has agreed to proceed with the CR, approval should be issued to produce a VP. This plan must be all encompassing. It must give assurance that all aspects of the proposed CR have been studied and the CR impact on existing facilities, utilities, product and personnel have been defined and the appropriate corrective or support actions planned for. A fully detailed User Requirements Specification (URS) can now be authored reviewed and published. Since developing the URS may raise problems that could not be anticipated when the VP was raised; there must now be a VP review to ensure all aspects of the final approved URS are authorized and planned for.
With an approved VP in place, a start can be made in authoring, reviewing and publishing the qualification protocols that are required to verify that all the requirements documented in the URS and all applicable cGMP requirements are complied with. These are:
- Design Qualification (DQ).
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (P1Q).
- Process Qualification (P2Q).
Where vendor developed Functional Specifications (FS) and or Design Specification (DS), are available they should be reviewed and referenced in the VP. Where these documents are not available a DS or FS may have to be retrospectively developed. The Design Qualification (DQ) must be used to verify that this FS or DS (if proceeded with) will deliver a system compliant with all requirements in the URS and the applicable cGMP rules and regulations. The execution of this DQ must verify that the proposed design will;
- Perform as specified in the URS.
- Conform to all mandated cGMP requirements.
- Operate in a manner safe to the product, and the operations staff.
The installation of each validatable system must be subjected to, and satisfy, a pre-approved Installation Qualification (IQ) protocol. When the requirements of the IQ have been satisfied, all aspects of the operational capabilities of each system must be fully challenged and verified by the execution of a pre-approved Operational Qualification (OQ) protocol. As soon as the executed IQ and OQ protocols having been reviewed and approved, a pre-approved Performance Qualification (P1Q) protocol or Process Qualification (P2Q) (this requirement will be documented in the VP) must be issued for execution. The execution of this PQ must verify that the system performance requirements, as specified in the URS have been achieved, and that the system operates in a manner safe to the product and production personnel.