Validation qualification

Retrospective validation Qualification Validation carried out by review of historical records How an individual element of an overall validation programme performs. When validation of that specific element is complete, it is qualified . When all elements are (satisfactorily) completed the system is validated... 

Cloud R, Pharmaceutical Equipment Validation Qualification, Interpharm Press, Buffalo Grove, IL, 1998. 

Prepare validation/qualification protocols and the applicable procedural controls... 

The criticality, or product risk, must be assessed for both the direct and indirect impact of the computer system on the product. The extent of the validation/qualification activities to be carried out will depend on the results of this assessment. The criticality is based on the potential impact on the product, and existing data does not justify a lower rating. 

Once an analytical method (e.g., LC/MS/MS) is established, it is necessary to qualify or validate the procedure from a regulatory GLP perspective. The desired criteria for method validation/qualification include determining the lower and upper LOQ, inter- and intraday precision, specificity of the method, and linearity of the calibration curves (166). Validation/qualification must be performed in the presence of the representative biological matrix that will be used in reaction phenotyping. For CYP reaction phenotyping studies, the matrix of choice is a pool of human liver microsomes (166). 

Key words Validation Qualification Computers Software Analytical Laboratories... 

Because there is still a misunderstanding of terms such as validation, qualification and verification, these will be explained right at the beginning. It is also important to understand the terms computer system and computerized systems and the different types of software loaded on a computer, but other publications should be consulted for this type of information. 

Key words Validation Qualification Vendors Computers Analytical laboratories... 

Static, dust, power-feed voltage fluctuations and electromagnetic interference could influence the system. The extent of validation should depend on the complexity of the system. Hardware is considered to be equipment, and the focus should be on location, maintenance and calibration of hardware, as well as on validation/qualification. 

The purpose of a numbering system for the documentation is to ensure an unambiguous identification of each validation/qualification document produced within the field of application of the Validation Master Plan. The document number is a combination of letters and numbers with a length of 10 or 11 characters. An example of such a document number might be ... 

As was common with validation, qualification can be as broad as an entirely new line, or focused on a new or modified subpart, e.g. a new capper in a filling line. No matter how large, the important aspect is to ensure that the assessment covers all the possible interactions between constituent parts of the process (i.e. input and outputs), the materials being used and the operation of the process (i.e. operators). 

To put this into context, when bar code readers were just one part of an integrated quality system (e.g. supplier count verification, QC count checks on incoming deliveries, line receipt checks, line cleandown checks and reconciliation), only the function of the bar code readers needed to be the focus of attention. As a stand-alone system, full validation/qualification becomes a necessity and takes the issue away from the line and onto technical support (i.e. QA). Just as with the earlier vision inspection equipment, qualification is not just of the bar code reader and the detection performance, but also of the component quality, e.g. 

The person responsible for the water quality to be used in pharmaceutical preparations usually is the pharmacist who is also responsible for the preparation processes. This person is accountable for all procurement, validations, qualifications, maintenance, deviations and changes of the instaUation(s). He should always be fully informed about aU those aspects. This also applies when the water preparatiOTi installation is installed outside of the premises of the pharmacy e.g. in the premises of the technical services or any laboratory [11]. 

Aseptic handling Aseptic processing GMP Annex 1 < Antineoplastics Microbiological controls Monitoring < Validation Qualification... 

Production Quality control In-process controls Reconciliation Validation Qualification Cleaning Quarantine... 

Chapurlat, V. and Braesch, C. 2008. Verification, validation, qualification and certification of enterprise models statements and opporturrities. Computers in Industry, 59, 711-721,... 

WSRC, Reactor Operations Standing Instructions, Procedure V.6, "Walkdown Validator Qualification Program," Rev. 0. 

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