Installation Qualification (IQ)
Installation verification occurs at the user’s premises. It provides documentation certifying that all specifications and parameters* of the user’s installation environment comply with the manufacturer’s description and safety requirements.
Operation Qualification (OQ)
Operation verification is performed after installation and repeated at regular intervals, recommended by the manufacturer, and confirmed by the customer. It provides documentation that all equipment components meet factory specifications and operate properly during the specified operating hours.
Design Qualigivation (DQ)
Design Validation is the establishment of a design that verifies that during the creation of a facility, including plant and ancillary systems, the design has been reviewed and confirmed that due consideration has been given to all specifications and requirements related to product quality and that it is reflected in the drawings (shop drawings, Written certification in pipeline instrumentation diagrams, etc.
Performance Qualification (PQ) Operational Validation Proof that the device (system) is suitable for performing specific analysis tasks. It can only use the user’s sample according to the user’s method regulations, against CAMAG’s OQ and the corresponding instrument manual, CAMAG assists the customer to carry out the certification himself.
IQ and OQ are performed similarly to fully documented technical test acceptance; PQ, on the other hand, requires individual validation plans for each facility and its associated processes. Examples of PQ inspection items are temperature distribution (e.g. inside the autoclave), the input power of the stirred axe reactor, and material distribution status. It requires a good understanding of facility equipment and process methods. At the same time as PQ, process validation should begin. Process validation aims to demonstrate that the process in question consistently achieves the desired results. Sometimes OQ, PQ, and PV (Process Validation) are often divided differently due to differences in purpose and concept. In fact, the name of the confirmation activity is not important, it is important that the company has a uniform set of rules to ensure that all required confirmation activities can be included IQ, Installation Qualifications.
The prerequisite for installation qualification is that the design qualification has been completed, and the deviation of the relevant DQ has been resolved or will not affect the installation qualification. Installation confirmation covers:
1. Location of equipment or facilities
2. Construction of equipment and facilities (unpacking acceptance part, relevant parts or key parts of the certificate, inspection report, electrical part, etc.) 3.
Material inspection in direct contact with the product
4. Inspection of lubrication parts
5. Pre- and post-installation cleaning inspection
6. Installation prerequisite check
7. Installation process inspection
8. Installation result inspection
The general format is:
4.0 Authentication Type
5.0 Validation Team Member Training
6.0 Installation Confirmation
6.2 Document and drawing confirmation
6.3 Installation confirmation of main equipment
6.4 Confirmation of equipment components
6.5 Confirmation of material in direct contact with the drug
6.6 Confirmation of pipeline distribution line
6.7 Confirmation of instrument
6.8 Confirmation of circuit connection
6.9 Confirmation of lubricating oil
6.10 Confirmation of auxiliary equipment
6.11 Confirmation of control valve
7.0 Deviation Summary Report
8.0 Installation Confirmation Conclusion