ולידציה – Installation Qualification (IQ) Protocol
Preparation Overview – part 1
The Installation Qualification (IQ) protocol is part of the validation documentation that covers the verification of the proper installation and operation of the system under validation in the user's facility. This IQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user's facility in proper environmental conditions.
The IQ protocol is designed to verify that the system under validation is properly installed and can be properly operated according to the supplier's requirements and the user's specifications. It must be reviewed and approved prior to the IQ performance.
Installation Qualification (IQ) Protocol Contents
The IQ protocol is structured in a relatively standard fashion, with predetermined chapters and sections, where the final contents are tailored according to the type and size of the system under validation.
:The IQ protocol includes the following chapters and sections
Document Approvals – contains a table that lists the supplier's and user's personnel required to approve the protocol
Participants – contains a table with the supplier's and user's personnel that participate in the validation process and approve their participation
Responsibilities – lists the roles of supplier's and user's personnel responsible for writing and approving the protocol
Glossary – lists the acronyms used in the protocol
IQ Validation Approach – defines the scope of the IQ process, and the requirements for its successful completion
IQ Test Procedures – this is the main part of the protocol, and provides the description of the test procedures and the result tables for filling and approving the test results
IQ Approvals – contains a table with the user's personnel responsible for reviewing and approving the test results, summary reports and conclusions
Appendices – include validation deviation forms and the documentation list with all the documents and drawings relevant to the IQ process
This is the first part of the preparation overview in Installation Qualification (IQ) protocol, the second part is IQ Test Procedures which will be discus elaborately in our next article.