3.1. Qualification activities should consider all stages from initial development of the user requirements specification through to the end of use of the equipment, facility, utility or system. The main stages and some suggested criteria (although this depends on individual project circumstances and may be different) which could be included in each stage are indicated below:
User requirements specification (URS)
3.2.The specification for equipment, facilities, utilities or systems should be defined in a URS and/or a functional specification. The essential elements of quality need to be built in at this stage and any GMP risks mitigated to an acceptable level. The URS should be a point of reference throughout the validation life cycle.
Design qualification (DQ)
3.3.The next element in the qualification of equipment, facilities, utilities, or systems is DQ where the compliance of the design with GMP should be demonstrated and documented. The requirements of the user requirements specification should be verified during the design qualification.
Factory acceptance testing (FAT) /Site acceptance testing (SAT)
3.4.Equipment, especially if incorporating novel or complex technology, may be evaluated, if applicable, at the vendor prior to delivery.
3.5.Prior to installation, equipment should be confirmed to comply with the URS/ functional specification at the vendor site, if applicable.
3.6.Where appropriate and justified, documentation review and some tests could be performed at the FAT or other stages without the need to repeat on site at IQ/OQ if it can be shown that the functionality is not affected by the transport and installation.
3.7.FAT may be supplemented by the execution of a SAT following the receipt of equipment at the manufacturing site.
Installation qualification (IQ)
3.8. IQ should be performed on equipment, facilities, utilities, or systems.
3.9. IQ should include, but is not limited to the following:
i.Verification of the correct installation of components, instrumentation, equipment, pipe work and services against the engineering drawings and specifications;
ii.Verification of the correct installation against pre-defined criteria;
iii.Collection and collation of supplier operating and working instructions and maintenance requirements;
iv.Calibration of instrumentation;
v.Verification of the materials of construction.
Operational qualification (OQ)
3.10. OQ normally follows IQ but depending on the complexity of the equipment, it may be performed as a combined Installation/Operation Qualification (IOQ).
3.11. OQ should include but is not limited to the following:
i.Tests that have been developed from the knowledge of processes, systems and equipment to ensure the system is operating as designed;
ii.Tests to confirm upper and lower operating limits, and /or “worst case” conditions.
3.12.The completion of a successful OQ should allow the finalisation of standard operating and cleaning procedures, operator training and preventative maintenance requirements.
Performance qualification (PQ)
3.13.PQ should normally follow the successful completion of IQ and OQ. However, it may in some cases be appropriate to perform it in conjunction with OQ or Process Validation.
3.14.PQ should include, but is not limited to the following:
i.Tests, using production materials, qualified substitutes or simulated product proven to have equivalent behaviour under normal operating conditions with worst case batch sizes. The frequency of sampling used to confirm process control should be justified;
ii.Tests should cover the operating range of the intended process, unless documented evidence from the development phases confirming the operational ranges is available.
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