Equipment validation covers all production equipment and systems that affect product quality or safety. Typical validation targets include process equipment, washing machines, autoclaves, packaging lines, and refrigeration equipment such as refrigerators, freezers, and liquid nitrogen freezers.
Equipment validation is based on the EU GMP, Annex 15, Qualification and Validation requirement, and is performed according to an approved User Requirements Specification (URS) and validation plan. The objective is to ensure that equipment and processes operate consistently as designed and deliver results that meet defined quality standards.
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.
All stages of equipment validation are thoroughly documented to ensure traceability and regulatory compliance. Documentation includes the validation plan, testing protocols, measurement data, and deviation reports.
Upon completion, a dedicated equipment validation report is prepared, summarizing all findings and results. The report includes all test materials demonstrating that the equipment meets its intended and regulated requirements.
Comprehensive and traceable documentation facilitates regulatory inspections and serves as an essential tool for ongoing quality management and equipment maintenance.
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).
By choosing Feicon, you gain a partner who offers:
Feicon ensures that validation is carried out correctly, on time, and in support of your business.
The best results are achieved when contact is made already at the design or procurement stage. This ensures that equipment, facilities, and processes are planned from the start with validation in mind. Considering validation needs early in construction also helps prevent delays and additional costs later.
Yes. We have performed equipment validations in a wide variety of production and laboratory environments. Our experience covers pharmaceutical process equipment, hospital and research facility systems, as well as washing and sterilization equipment, packaging lines, and various refrigeration units.
Equipment validation typically includes a User Requirements Specification (URS), validation plan, test protocols, measurement results, deviation reports, and a final validation report. All stages are documented thoroughly to ensure regulatory compliance and traceability.
Validation is typically performed before equipment commissioning or after significant changes. It is also recommended to revalidate periodically, especially when modifications are made to the equipment, software, or processes that may affect performance.
Often, yes. Equipment validation requires specialized expertise in GMP requirements, measurement methods, and documentation. Using experienced experts ensures that every phase meets the required standards and that results withstand regulatory inspection.
Yes. It is often practical to perform system or cleanroom validation alongside equipment validation, allowing the entire production environment to be verified as one comprehensive and compliant whole. This approach saves time and simplifies coordination.
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