GMP-compliant Qualification in the Pharmaceutical and Biotech Industry
Design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) are thoroughly supported by Valicare GmbH. Our customer specific documentation is based on current GMP requirements.
An efficient system for change and deviation handling guarantees a documented evidence for executed actions and changes. Only trained and experienced personnel qualify the equipment on-site. Measured values and raw data are completely documented, exactly evaluated and are traceable at any time.
The design review within the DQ 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 in order to reveal the design weak points as soon as possible and eliminate them before construction and execution of a factory acceptance test (FAT).
On the basis of our experience in mechanical engineering and plant construction as well as in qualification of pharmaceutical production equipment and facilities, Valicare GmbH can give a quick support for preparation of your system specifications, e.g. user requirement specification (URS) and functional specification (FS).
Valicare GmbH supports with the preparation and editing of customized URS for your equipment, facilities, utilities, etc. and creates a structured basis for further project and qualification steps. The URS describes all requirements that your system should fulfil.
Based on the URS, Valicare GmbH supports your team for the development of the FS or for the complete new preparation of the document. The FS describes the technical implementation of the defined URS.
Valicare GmbH prepares the test protocols for the factory acceptance test (FAT) and the site acceptance test (SAT).These plans provide the evidence, that the equipment fulfils the functions and specifications required in the URS and described in the FS. With long time experience, Valicare prepares the test protocols in such a way, that the test effort for further qualification steps such as initial qualification or operational qualification is kept as low as possible.
Due to our multidisciplinary team, we are able to identify technical issues fast and precise and turn them into specifications.
All our documentation is GMP-compliant and offers the clearly structured content for an efficient and targeted qualification. We work according to the standards of GAMP 5 guideline 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. Additionally appropriate actions for minimizing of the risks are defined.
The creation of the risk assessment will be done 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 of devices, equipment, aggregates, etc. and determines the responsibilities.
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. Within the design qualification (DQ) the implementation of user requirements in the process is checked.
The system functions are analysed within a system-specific risk assessment and if necessary additional qualification checks are defined. This enables an efficient definition of qualification test scope.
The comparison of the „as-built“ status against the specified requirements „as designed“ proceeds within the installation qualification (IQ). Based on clearly structured test sheets, the main equipment and the periphery machines are checked on-site for correct installation.
We check the verification of process-critical parts, as well as the interfaces between media, upstream and downstream machines and systems. Furthermore 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, etc. are checked.
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 and agreed with the customer in structure, content and acceptance criteria according to the URS, the risk analysis and the existing knowledge about processes, systems and equipment.
The execution of the tests is done by experienced Valicare validation engineers using our calibrated and qualified measuring devices which are state-of-the-art.
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 the customer requirements. The successful 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 (if applicable further specifications), risk assessment, IQ, OQ and PQ. The traceability matrix ensures that all requirements are checked and fulfilled.
A regular requalification of critical equipment is required according to GMP guidelines. Based on an initial qualification, critical parameters are rechecked at defined time intervals and normally with reduced test scope.
Valicare GmbH offers a comprehensive service for the GMP-compliant requalification of equipment and machines (e.g. autoclave, 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.