Installation Qualification (IQ) is the documented verification that equipment, devices, and systems have been installed in accordance with regulations, in compliance with the requirements of EU-GMP Annex 15 and FDA Process Validation Guidance. It is a technical term from the field of quality management. In the classic qualification model, the IQ follows the Design Qualification (DQ) and precedes the Operational Qualification (OQ) and Performance Qualification (PQ).
The IQ is relevant for many industries; in pharmaceutical production, it forms the basis for GMP compliance (GMP stands for Good Manufacturing Practice, a quality assurance system for pharmaceuticals). It is mandatory to meet GMP requirements and regulatory proof obligations to authorities such as the FDA and EMA.
Aspects of the IQ and typical contents
Typical aspects and contents of an IQ depend strongly on the respective process or system. The following criteria usually play a role in the pharmaceutical industry:
- Inspection of the installation site: Checking media connections, compliance with cleanroom requirements, existing connections, and other site-specific factors.
- Specification comparison: Comparison of installed modules and components (materials, sensors, software) with the plan.
- Documentation control: Verification of system-specific documentation, including circuit diagrams and manuals.
- Inspection of supply connections: Proof that supply lines and connections, such as water, nitrogen, or compressed air, are correctly installed.
Additionally, there may be other possible contents, such as recording calibration certificates. In the course of the IQ, a test protocol is then created, which represents the result to some extent.
The process of the IQ
The process of installation qualification is typically divided into three main parts: planning, execution, and documentation. In the first step, planning, the IQ plan is created. It usually contains checklists and specific test criteria. If necessary, a risk assessment is also created. Additionally, the test plan for the subsequent process is defined.
The execution is based on the previously defined test plan. It usually begins with inventory recording. This is followed by documentation review (review of manufacturer documentation) and technical equipment inspection. On-site, the connections are also inspected. Furthermore, programs are also subjected to testing.
This is followed by the OQ (Operational Qualification), the next step in the qualification process. For this, testers prepare test protocols as well as the final report of the IQ.
Relevance and importance of installation qualification for the pharmaceutical industry
The pharmaceutical industry is one of the sectors where qualification and verification are particularly crucial. Not only must systems meet the highest requirements for product quality to produce medically effective preparations, but they must also comply with various regulatory requirements for both production and quality assurance. The IQ is therefore an essential part of the documentation that demonstrates to authorities that the systems meet specific requirements, such as compliance with FDA, EMA, GMP, or other relevant standards.
Other industries, other IQ
As part of quality management, installation qualification is also of importance in other industries. In chemical and technical production, it serves to qualify reactors and laboratories. It is also part of the commissioning of production systems in the food industry, for example, during the installation of packaging lines. Other sectors also regularly apply IQ, ranging from mechanical engineering to agriculture.
Challenges in installation qualification
The main challenges of IQ arise from the extensive documentation required for pharmaceutical systems. High regulatory and legal requirements demand appropriate expertise. Therefore, companies often prefer to rely on external expertise for IQ execution. Additionally, the process is time-consuming, which incurs costs. Rommelag supports operators through standardized, documented processes that reconcile speed and thoroughness, representing one of the most significant challenges in quality management.
For a smooth process, it is therefore essential to provide resources, expertise, and personnel. It has also proven effective when manufacturers such as Rommelag and operators work closely together to install systems quickly and successfully. In this way, further requirements can also be best implemented, such as traceability of all components. Those who invest the necessary resources and rely on the manufacturer's expertise secure a system that is quickly ready for operation and comprehensively qualified.