The extent and intricacy of a qualification exercise are often connected to the complexity of the equipment in question and the essential role that equipment plays in ensuring the quality of the final product.
Installation and operational qualification exercises guarantee, through suitable performance tests and accompanying documentation, that the equipment, along with its ancillary systems and sub-systems, has been properly commissioned.
As a result, all subsequent operations will be dependable and adhere to the specified operating limits.
The basic principles are:
- Equipment must be installed properly in accordance with the installation plan.
- Calibration, maintenance, and cleaning requirements should be addressed in approved Standard Operating Procedures (SOPs).
- Tests must be performed to ensure that the equipment is functioning correctly under both normal and “worst case” scenarios.
- Training requirements for operators regarding new equipment must be carried out and documented.
At different phases of a validation process, it is essential to have protocols, documentation, procedures, equipment, specifications, and acceptance criteria for test outcomes. All of these elements must be reviewed, verified, and approved. It is anticipated that representatives from relevant professional fields, such as engineering, research and development, manufacturing, quality control, and quality assurance, will be actively engaged in these activities, with the ultimate authorization provided by a validation team or the quality assurance representative.
Installation Qualification (IQ):
The Installation Qualification (IQ) is a process that confidently verifies that all primary processing, packaging equipment, and associated systems comply with installation specifications, equipment manuals, schematics, and engineering drawings. This validation phase encompasses the assessment of equipment design, as well as the identification of calibration, maintenance, and adjustment needs.
In cases involving complex or large equipment, a pharmaceutical manufacturer may choose to perform a pre-delivery inspection of the equipment at the supplier’s assembly site. It is important to note that this pre-delivery inspection does not replace the installation qualification. Nonetheless, it is recognized that the inspections carried out and documented at this stage may overlap with several of the inspections performed during the IQ phase, potentially resulting in a reduction of the IQ inspection scope.
All equipment, gauges, and services must be properly identified and assigned a serial number or another reference number. This identifier should be included in the reports for the equipment validation studies that are conducted.
The installation qualification necessitates a formal and systematic evaluation of all installed equipment against the specifications provided by the equipment supplier, along with any additional criteria specified by the user as part of the purchasing specifications. These evaluations, tests, and challenges should be repeated multiple times to ensure reliable and significant outcomes.
During the IQ phase, the company is required to document the preventive maintenance needs for the installed equipment. The preventive maintenance plan should be integrated into the regular maintenance schedule.
Operational Qualification (OQ):
The execution of an operational qualification must adhere to an approved protocol. At the OQ stage, the essential operating parameters for the equipment and systems need to be determined. The OQ plans should outline the studies to be conducted on the critical variables, the order of these studies, the measuring instruments to be utilized, and the acceptance criteria that must be satisfied.
Research on the essential variables must encompass a specific condition or a series of conditions that include both upper and lower processing and operating limits, commonly referred to as “worst-case” conditions.
The successful completion of an Operational Qualification (OQ) should facilitate the finalization of documentation related to operating procedures and operator instructions for the equipment. This documentation ought to serve as the foundation for training operators on the necessary requirements for the satisfactory operation of the equipment.
The successful completion of both Installation Qualification (IQ) and OQ activities should enable a formal “release” of the equipment for the subsequent phase in the process validation exercise, provided that calibration, cleaning, preventive maintenance, and operator training requirements have been finalized and documented.