Validation training verification

GLP regulations require QA personnel to inspect/audit each study conducted, but the extent to which QA personnel are involved in software development and the val-idation/verification process varies from company to company. In some companies, there is little or no QA involvement in these processes, whereas in others QA personnel are involved. QA personnel can provide assistance in the area of vendor audits for purchased software or can conduct inspections of in-house software development to ensure that internal procedures are being followed. QA personnel, who conduct in-process inspections and review the resulting data and validation report for accuracy, could provide inspection support during the validation and verification process. During system development and validation, properly trained QA personnel can provide the regulatory advice needed to ensure that the system will meet government standards. QA personnel become more familiar with the system(s) that will be used when they are involved early in the validation process. 

Table 2 Training Verification to Include Training on Standard Operating Procedure (SOP) 123 and Training on This Validation...

The Nordic Committee on Food Analysis has published a guideline on the Validation of Chemical Analytical Methods which differentiates between external validation work carried out on published methods and that work required to transfer it into the working laboratory to confirm its suitability for use. Table 20 is adapted from this document. This document is most easily accessed from a recently published book If certified reference materials are available they should be used to confirm the verification of trueness. These guidelines could also apply to intra-laboratory training programmes. 

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

Qualifications of personnel Services available Offered procedures Capability to complete project Quality controls program Quality assurance program Review and approve contracts Future compliance audits Database management Validation/verification needs Contract laboratories Procedures Facilities/equipment Personnel qualification Training Methodology... 

Section 3.7 Design Verification. Includes a description of the approach and methods planned to verify that the design architecture, established from synthesis, is both upward and downward traceable to the functional architecture and satisfies the requirements of the validated requirements baseline and supports baseline of configurations and specifications (including the human engineering, manpower, personnel, safety, and training specification). 

Once created by the author, reviewed by quality management, and released/approved by management, specification documents, for example, SOPs are valid. They are distributed to the area of application (scope), relevant personnel are trained and the document can then be applied. After application, the related verification documents are collected, organized, and relevant parts thereof are published, for example, a CoA as an extract from a set of data, which in turn consists of a further set of raw data and meta-data. 

Obviously, only trained and qualified analysts should be allowed to operate the mass spectrometer. However, in addition to the practical considerations around this topic, an up-to-date record of the qualifications of each analyst should be maintained in the laboratory s facility records, which can be cited as verification that the analyst who performed the analyses in support of the generation of data used to support validation and sample analysis was indeed qualified to do so. 

Comprehensive system and assembly requirements (upper sector in Fig. 5.8) are valid for all components and assemblies of a department, such as the power train development at Volkswagen. As an example, they can provide mles for the verification of every CRD. General assembly requirements (middle sector in Fig. 5.8) specify the corresponding component or assembly. They are valid for all variants of the component and thus included in every requirements docmnent of the assembly as common requirements. Specific assembly requirements (lower sector in Fig. 5.8) specify certain variants of a component or an assembly. 

Observation of the Cherenkov radiation from irradiated reactor fuel assemblies is used to obtain qualitative confirmation (attribute testing) of the presence of spent fuel in storage by scanning rows of assemblies from the pool bridge. Characteristic patterns formed by the arrangements of rods and holes in fuel assemblies have to be observed to ensure a valid verification. A well-trained inspector can easily detect the presence of an inactive dummy assembly surrounded by highly active neighbors. 

Background documents developed during the EOF development process, justifications for application of the reference development method, relevant supporting studies, specific thermalhydraulic calculations, verification of EOF strategies and validation reports, training materials, etc. 

Certification is a second-level verification that personnel have demonstrated the desired levels in every qualification category (education, experience, medical, training, and job performance) and are periodically evaluated to assure they maintain that level. Certification is required for those positions which independently manipulate or direct the manipulation of reactor controls, fuel charge/discharge machines, or equipment which directly impacts the reactivity of the core. Certification shall be valid for a period of 2 years. Positions requiring certification shall include ... 

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