Equipment Validation

We perform equipment validations for, for example, production equipment and processes, washing machines and autoclaves. Equipment validation is based on the EU GMP, Annex 15, Qualification and Validation requirement, and is performed based on an approved user requirement (URS, User Requirements Specification) and validation plan.

Equipment validation is performed in four stages:

1. Design Qualification (DQ)
A design inspection, which is carried out when the equipment or part of it is tailored to client needs. DQ ensures that all user requirements have been taken into account in the design.

2. Installation Qualification (IQ)
An installation inspection, which verifies the correctness of the installations and compliance with the requirements. IQ ensures the mechanical installation of the equipment as well as the installation of commodities and system connections.

3. Operational Qualification (OQ)
Functional testing, which verifies the correctness and compliance of the equipment’s basic functions. OQ ensures the functionalities of equipment control, safety and system connections.

4. Performance Qualification (PQ)
Performance testing, where equipment performance and functionality are checked as part of the overall process. PQ ensures equipment capacity, the absence of disruptions and general functionality in the final installation environment and configuration.

The performance of the equipment validation is documented with a separate equipment validation report, to which the material of the performed validation testing is attached.

We offer our clients equipment validation expertise on a turnkey basis, whereby we prepare and get approval for the user requirement, prepare the validation testing protocol, perform the validation testing, and prepare and get approval for a validation report.

If necessary, we also prepare operating instructions and provide training on the use of the equipment and the maintenance of validity (SOP, Standard Operating Procedure).

In terms of equipment validations, we have over twenty years of extensive experience in the following equipment, among others: pharmaceutical manufacturing process equipment, packaging lines, washing machines, sterilization equipment, QC equipment, refrigeration equipment (refrigerators, freezers, sensitive freezers, deep freezers, liquid nitrogen freezers).