Introduction
This procedure provides guidance in the qualification of simple, moderate, and complex laboratory equipment that is used in an analytical laboratory in a Good Manufacturing Practices (GMP) environment associated with products in or intended for the market place.
1. Exemption of Equipment from Qualification and the rationale for the exemption should be documented (e.g., in the VMP or SOP). Examples of exempt equipment include, but are not limited to, the following:
– Equipment that does not require installation for use (e.g., thermometers, hand-held thermocouples, certified equipment); or
– Equipment that is a non-critical factor in the generation of a result.
2. Documentation of Qualification Activities Performed at the Site by a Vendor (e.g., protocols and results) should be obtained, reviewed, and approved by the Quality Authority.
3. The System Owner should ensure that the equipment vendor follows a quality system approach. This can be accomplished by one of the following:
– Site approved vendor;
– Previous industry and/or experience with the vendor and/or system;
– Vendor assessment -vendor assessment may include documentation provided by the vendor or specific request for information that may include vendor surveys; or
– Vendor audits.
For example, simple or moderate laboratory equipment obtained from common well-known manufacturers, and models used throughout the industry, do not require vendor audits. When purchasing complex off-the-shelf equipment from well-known manufacturers, a vendor audit may not be required, if a statement from the vendor is obtained documenting the vendor’s software quality assurance program (e.g., an ISO certificate or similar industry certification).
4. The Process for Assessing Laboratory Equipment should be established and documented (e.g., SOP, VMP). Assessment for new GMP equipment should be completed prior to use of the equipment. Equipment that has been previously qualified or calibrated and is in a change control/maintenance program may be excluded from the assessment.
5. Post Qualification Changes That Might Impact the Equipment Qualification Status should be addressed by established change control and/or investigation SOPs.
6. When Performing Re-qualification Activities, an assessment of the original equipment qualification documentation should be performed to determine which qualification tasks need to be re-executed to demonstrate suitability of the equipment for continued use. The re-qualification activity should be documented and approved by the system owner and Site Quality Team.
7. Equipment Qualification Documents should include the following equipment information, at a minimum:
– Description, and
– Unique Identifications. Qualification documentation package for equipment should include the following information, at a minimum:
– Required documents as specified in Appendix 1 based on the equipment classification;
– Intended end-use of the equipment, and
– Equipment classification.
– A process or procedure should exist to ensure all documents related to individual equipment qualifications are retrievable.
8. Installation Qualification (IQ) should ensure that the instrument has been installed as specified, (e.g., plugged-in), located and configured in accordance with the manufacturer’s guidelines.
– The IQ instructions or protocol for a Simple, Moderate, or Complex off-the-shelf piece of equipment should be approved by the Quality Authority prior to execution including vendor provided documentation.
9. Operational Qualification (OQ) should ensure that the instrument is operating as specified by the manufacturer: OQ instructions or protocols, including those received from the vendor, should be approved by the Quality Authority prior to execution.
– For simple and moderate equipment the OQ requirements may be replaced and supported by the initial calibration.
– For complex systems, OQ should include critical instrument test parameters defined for the intended use and purpose of the instrument. Calibration data may be used to support OQ of complex instruments, but cannot replace OQ.
– OQ should focus on the operation of each component. The OQ may be conducted according to the manufacturer’s instructions or recommendations (if available), focusing on each components operation. Alternatively, tests that involve the entire system may be substituted for component testing.
10. For Moderate and Complex Equipment that Stores Data Electronically, procedures and processes should be in place to ensure data integrity and security.
– For complex equipment, aspects of system security, configuration, and electronic data and electronic signatures should be addressed in a local Site procedure or equipment specific protocol or plan.
– Supplemental qualification tests should be performed for complex equipment with personal computers (PC) connected to the server to verify proper configuration of the system and to verify establishment of the proper user permissions.
11. Performance Qualification (PQ) should ensure that the instrument is performing as specified, and configured in accordance with the intended use in the laboratory.
– The PQ instructions or protocol for an off-the-shelf piece of equipment, including vendor provided documentation, should be approved by the Quality Authority prior to execution.
– For moderate equipment, the PQ requirements may be met through the initial calibration provided that the calibration includes the range of intended use at the Site, which is conducted as part of the qualification exercise.
– For complex equipment, PQ should include testing using all modules of the equipment and should be reflective of the intended end-use.
– PQ may be achieved through method transfer or method validation if the intended end use of the equipment is addressed.
– Moderate equipment routine use of system suitability and/or control samples may satisfy PQ requirements.
12. Periodic Reviews should be performed to determine the current status of the equipment and the need for re-qualification, and shall include at a minimum, the review of:
– Equipment performance (PM, calibration, system suitability, error logs);
– Changes to the equipment;
– Changes to the intended use;
– Changes in equipment classification; and
– Equipment related deviations and investigations.
13. Plans or SOPs for Decommissioning Qualified Laboratory Equipment should address, at least, the following elements:
– Qualification and calibration documentation,
– Hardware, and Electronic data, if applicable.