Validation Final Reports

The Final Report summarizes the results of the validation process and provides an analysis of the test data in support of the conclusion that the equipment or system demonstrates consistent performance within the established acceptance criteria. Deviations and/or exceptions to approved protocols, along with suitable explanations and justifications, are also documented in the Final Report. 

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Enhanced turn-over package Installation qualification protocols Operational qualification protocols Change control initiation Cycle development Performance qualification protocol Process validation protocols Validation final reports Validation package Certificate for use in manufacturing Required protocols and procedures for dry production Required protocols and procedures for liquid and semisolid products... 

My attempt of depicting the new frontiers for Quantum Chemistry has no produced exhaustive and detailed indications. It is almost impossible to present in a few pages indications of this type, of questionable validity even tf expressed as final report of a panel of experts, after a hard collective work on this theme. Quantum Chemistry is in fact one of the cornerstones of Chemis, enjoying good health as the other branches of Chemistry, and there are ample and varied perspectives of progress. A selection of some themes woitld means to indulge too much to personal tastes. 

A number of computer software packages are available to the analyst to assist in the planning and execution of both method development and validation experiments. The attraction of these systems is that they can automate the validation process from planning the experiment to test execution to the presentation of the data in a final report form. 

An essential requirement of any data storage and retrieval system is data validation to ensure that neither incorrect nor dupHcate data are entered onto the main storage file which is used to generate the final reports. This preventative screen is required at four stages during the conversion of the cigarette sample into smoke chemistry values on the database. 

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

MICROBIOLOGY VALIDATION REPORT STERILITY TEST OF (PRODUCT NAME) TEST FOR BACTERIOSTASIS AND FUNGISTASIS FINAL REPORT... 

Gunderson, E. C. and Anderson, . C., "Development and Validation of Methods for Sampling and Analysis of Workplace Toxic Substances," November, 1979, Final Report on NIOSH Contract 210-... 

During the 1990 Washington Conference on Analytical Methods Validation Bioavailability, Bioequivalence and Pharmacokinetic Studies [1], parameters that should be used for method validation were defined. The final report of this conference is considered the most comprehensive document on the validation of bioanalytical methods. Many multinational pharmaceutical companies and contract research organizations contributed to its final draft. This scientific meeting was sponsored by the American Association of Pharmaceutical Scientists (AAPS), the Association of Official Analytical Chemists (AOAC), and the U.S. Food and Drug Administration (FDA). The conference report has been used as a reference by bioanalytical laboratories and regulatory agencies worldwide. 

The glossaries in the 1990 and 2000 Washington conference final reports [1,3] define most of the analytical terms used in the validation of a method. However, internationally accepted definitions such as those by ISO or IUPAC already exist and have been elaborated carefully over many years [2,6]. The definitions reported in the 1990 and 2000 Washington conference final reports sometime agree only partially with the ISO and IUPAC. Following are some examples for comparison. 

Recovery. In the 2000 Washington Conference final report it is clearly stated that knowledge of recovery is not essential to assay validation, but it does provide useful information about the real amount of analyte that is being analyzed. Assessment of recovery at every step of sample preparation and analysis in which losses may occur provides a powerful diagnostic tool to improve the method if needed. If a good internal standard has been chosen, the losses will have no impact on quantitation because they will be similar for analyte and internal standard and will thus annul each other. On the other hand, recovery is very important to verify if the internal standard really mimics and matches the analyte. The discovery of significant and inconsistent differences in recovery between analyte and internal standard at different steps of sample cleanup and analysis could indicate possible failure of the method during the validation. 

The 1990 and 2000 Washington conference final reports and FDA guidance for the industry state that partial validation is required with a change in species within... 

Adler, E.V. and Bums, M., Drug Recognition Expert (DRE) Validation Study, Final Report to Governor s Office of Highway Safety, State of Arizona, 1994. 

Validation trials Validation finding Final report and recommendations... 

On satisfactory completion of the computer system qualifications, with PQ conducted in conjunction with a successful process validation, a final report must be prepared by the pharmaceutical manufacturer s validation team. This is normally referred to as the validation report. The objective of the report is to give an overview of the results of the execution of the validation program for the computerized operation and to draw a conclusion as to the suitability of the computerized operation for pharmaceutical manufacturing. This may be unconditional use or there may be restrictions. In the latter case the proposed remedial ac-tion(s) must be approved and, as applicable, considered under change control. A schedule to complete any outstanding actions must be documented and progress formally reported. 

The final validation report or summary is prepared after careful review of the data gathered during execution of the protocols. These data should be compared with approved acceptance criteria. The appropriate representatives of the validation team are usually those who approved the protocol and review and sign the final report and associated accompanying documents. 

At the completion of the documentation, a final report should be drafted to indicate the conclusion and acceptability of the installation. The final report must be approved by the departments that approved the protocol. These are likely to be engineering/technology, production quality assurance/quality control and operations, and the validation manager. Approval of the final report by the relevant departments makes the way clear for proceeding with operational testing. 

The OQ final report is intended to summarize all relevant data that are collected during the validation run. The report gives a short description of all test functions and a discussion of the overall validation. This compilation is adequate documentation of assurance of the acceptability and validity of the packaging equipment. The basis for this assurance is the result of the data, test functions, and supporting documentation. A dossier in sections is provided in Table 5. 

The GLP regulations boil down to this if you submit a study to a regulatory agency, then this study should have been conducted in a proper facility by qualified personnel, using properly maintained and calibrated equipment, following written standard procedures and checked routinely by an independent and qualified person. All the original data should be archived and it should be possible to validate the final report of the study by an audit of raw data. 

Winterle, J.S. and T. Mill. 1982. In Validation of estimation techniques for predicting environmental transformation of chemicals. Final report (Contract 68-01-6269) U.S. Environmental Protection Agency, Washington, DC. 

The most important parts of the cleaning validation protocol and final report are... 

Posthuma L, van Gestel CAM, Smit CE, Bakker DJ, Vonk JW. 1998. Validation of toxicity data and risk limits for soils final report. No. 607505004. Bilthoven (the Netherlands) National Institute of Public Health and the Environment (RIVM). 

After the completion of the study, a final report must be prepared. It should be produced as a detailed scientific document and contain the study purpose, methods and materials used, the summary, and the conclusions from the study. Any deviation(s) or otherwise with the QA statement should be part of the final report (Table 18-3). The study director should sign and date the final report only after full satisfaction that the findings are complete, true, accurate, comply with GLP, and are valid. 

FIFRA Environmental Model Validation Task Force. FIFRA Environmental Model Validation Task Force. Final Report April 27,2001. Obtainable via www.FEMVTF.com or via EPA citing MRID 45433201. 

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