Support for each qualification phase

The design review within the design qualification checks whether all defined user specific requirements (URS) are implemented or described in the functional specification (FS) and in other relevant design documents. The design review is executed during the development phase to reveal the weak points as soon as possible and eliminate them before construction and execution of a factory acceptance test (FAT).

User requirement specification (URS) / functional specification (FS)

Based on our experience in mechanical engineering and plant construction as well as in qualification of pharmaceutical production equipment and facilities, Valicare can support you by preparing your system specifications, e.g. user requirement specification (URS) and functional specification (FS).

Valicare supports you in preparing and editing customized URS for your equipment, facilities, and utilities, and creates a structured basis for further project and qualification steps. The URS describes all requirements that your system should fulfill.

On this basis, our experts support your team in developing the FS or in preparing a completely new document. The FS describes the technical implementation of the defined URS.

Factory acceptance test (FAT) / site acceptance test (SAT)

Valicare prepares the test protocols for the factory acceptance test (FAT) and the site acceptance test (SAT). These plans provide evidence that the equipment fulfills the functions and specifications required in the URS and described in the FS. Thanks to our long-term experience, the Valicare experts prepare the test protocols so that the test effort for further qualification steps such as initial qualification or operational qualification is kept as low as possible.

Our multidisciplinary team makes it possible to identify technical issues quickly and precisely and to turn them into specifications.

All our documentation is GMP-compliant and provides clearly structured content for an efficient and targeted qualification. We work according to the standards of GAMP 5 and consider current requirements of the Code of Federal Regulations CFR 21, Part 11 – electronic records & electronic signatures (ER/ES).

The technical risk analysis (RA) describes all possible failures and risks which can occur during the operation of the system and evaluates these failures with effect, probability, and detectability of risks. It further defines additional actions to minimize the risks.

The risk assessment is jointly developed in a workshop, which is coordinated and led by Valicare validation engineers. Customer representatives and experts of the involved departments should attend the workshop.

The Failure Mode Effects Analysis (FMEA) method is the standard method in the pharmaceutical industry. Valicare can also assist you with other risk assessment methods.

The qualification plan (Q-Plan) defines the overall qualification structure and describes the qualification scope for devices, equipment, aggregates, etc. and determines responsibilities.

Design qualification (DQ)

The long-term experience with pharmaceutical production equipment and facilities enables a fast and precise preparation of URS according to customer requests as well as FS in accordance with manufacturer information. The implementation of user requirements is also checked during design qualification.

The system functions are analyzed within a system-specific risk assessment. If necessary, additional qualification checks are defined. This enables an efficient definition of the qualification test scope.

Installation qualification (IQ)

The "as-built" status is compared with the specified requirements "as designed" during installation qualification (IQ). Based on clearly structured test sheets, the main equipment and the peripheral machines are checked on site for correct installation.

We verify process-critical parts, as well as the interfaces between media, upstream and downstream machines, and systems. The presence of technical documentation and certificates such as operating instructions and operating procedures, cleaning and maintenance requirements of the supplier, equipment drawings, calibration and material certificates, are also checked.

Operational qualification (OQ)

The operational qualification (OQ) is performed after the IQ and documents that the equipment can work without any failure within the defined acceptance criteria. The OQ test sheets are developed together with our customers regarding structure, content, and acceptance criteria according to the URS, the risk analysis, and the existing knowledge about processes, systems, and equipment.

Experienced Valicare validation engineers carry out the tests using our calibrated and qualified state-of-the-art measuring devices.

Performance qualification (PQ)

The performance qualification (PQ) shows the functionality and performance of the system under operating conditions. The test design and the acceptance criteria are developed according to customer requirements. The successfully executed tests demonstrate the performance of the entire system with all connected system components and complete the successful qualification.

The Traceability Matrix (TM) links all requirements of the URS with the corresponding descriptions in the FS, risk assessment, IQ, OQ, and PQ. The Traceability Matrix ensures that all requirements are checked and fulfilled.

Regular requalification of critical equipment is mandated by the GMP guidelines. Based on an initial qualification, critical parameters are rechecked at defined time intervals and usually with a reduced test scope.

Valicare offers a comprehensive service for the GMP-compliant requalification of equipment and machines (e.g. autoclaves, sterilizers, sterilization and depyrogenation tunnels, and isolators) as well as for facilities.

The requalification checks are performed with calibrated measuring devices. The results of qualification or validation are recorded in a GMP-compliant documentation in form of protocols and reports. Occurred deviations are documented, and corrective actions are proposed.