Qualification or validation?
The process validation represents both the substantial and formal demonstration of the ability of the process to provide (within pre-defined parameters) in a consistent manner results that meet specific requisites.
First of all, a general procedure must be defined, containing all the validation activities, the qualification, and the controlled management of changes.
Subsequently, the validation activities are planned, the processes are described and analyzed, the risks are identified, analyzed and evaluated and, finally, the validation of the process is planned and carried out.
The company must define a Validation Plan for each process that requires validation. The planning and execution of process validation is carried out in stages. First off, the expected results for the process are defined, the critical components of the process are identified and the corresponding expected requirements / performance are defined. Finally, the critical components are qualified.
The equipment qualification
“Qualification” can be defined as the testimony, supported by objective evidence, of the ability of an element of a process or a system to perform according to pre-established standards.
All the elements of the processes or systems previously identified as “critical” which significantly impact the quality of the expected results, must be qualified (establishment, areas, equipment, materials, operators) or validated (computerized management systems, methods).
The qualification of the equipment used in a process takes place through three phases. It is possible to proceed to the next phase only after verification of the correct completion of the previous qualification phase.
The first phase: Installation Qualification (IQ)
The first phase consists in checking the compliance of the equipment with the technical specifications declared by the manufacturer and the applicable safety regulations (i.e. electrical safety verification), checking the availability of the technical documentation and all the data that allow the correct identification of the equipment (manufacturer, type, model, serial number, etc.) and of the components, accessories or spare parts provided with the equipment.
The calibration status of any available measuring or control devices will be verified during this first phase, as well as the equipment setup and the correct connection to the utilities, its correct placement and installation on location.
Once all the verification tests have been successfully passed and the formal approval of the Head of the Organization (or their legal representative) has been obtained, the installation qualification is released, a fundamental step in order to move on to the next phase.
Second phase: equipment Operational Qualification (OQ)
The second phase consists in the equipment field testing in order to ensure its ability to perform as declared by the Manufacturer (and approved by the Organization) within the specified limits and under the expected operating conditions for the considered process. The field testing consists in the execution of tests according to pre-established protocols, whose criteria and acceptability limits must be clearly defined.
These tests should also include the simulation of the equipment usage under extreme conditions (worst case), for example at the maximum rotation speed of the tool provided in a lathe.
Furthermore, the following operations will be verified during this phase: the correct setting of the process parameters (e.g. temperature, pressure, speed, etc.), the correct interfacing with other equipment and computerized management systems (where applicable), the availability of all the documentation necessary for the correct use and management of the equipment and the skills of the personnel who will use the equipment.
Once these tests have been successfully passed, the availability of all the documentation necessary for the correct use and management of the equipment has been verified and the formal approval of the Head of the Structure has been obtained, the operational qualification is released. The release of this qualification is essential to move on to the next phase of qualification.
Third phase: equipment Performance Qualification (PQ)
Can be performed only if the previous qualification steps (IQ, OQ) have been successful. The third and last stage of the equipment qualification includes a series of tests aimed at ascertaining, in a reproducible way and in the real conditions of use (routine), that the expected results for the process have been obtained.
Once all the tests established for this phase have been successfully passed and the formal approval of the Head of the Structure has been obtained, the qualification of the service is issued, which in most cases coincides with the validation of the process itself.
Please keep in mind that the verification activities must be carried out according to previously defined specific protocols or company plans, with the support of qualified technical personnel (either internal or external staff) and their results must always be documented.
For more information:
- Quality Management Systems – Process Validation Guidance. GHTF/SG3/N99-10:2004 (Edition 2)
- Guidance for Industry Process Validation: General Principles and Practices – Current Good Manufacturing Practices (CGMP) Revision 1, 2011
Ing. Enrico Centin
Product Manager – QA/RA Consultant
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