Quality control validation reports

The method was validated in accordance to the guidelines of the international conference on harmonization (ICH). Data with respect to accuracy, within- and between run precision, recovery, detection and quantitation limits were reported and found to be within the accepted international criteria. Neither endogeneous substances nor the commonly used dmgs were found to interfere with the retention times of the analytes. Standard solutions of the dmg and quality control preparations at high and low level concentrations were demonstrated to be stable at room temperature and/or -20°C for long and short periods of time. 

This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

Baseline separation of the cephalosporin antibiotic cephradine, its main impurity cephalexin, and other related impurities was achieved by MEKC. The method was validated in compliance with the USP XXII analytical performance parameters and the results were comparable with a validated LC method, depicting CE to be a valuable alternative technique to LC in pharmaceutical quality control. In most cases, the amount of impurities relative to the main compound measured by MEKC is similar to that obtained by LC. However, some reports reveal that there are differences in number and amount of impurities between MEKC and LC analysis. MEKC permitted the determination of seven known and three unknown impurities in cefotaxime and the results were in good agreement with those of LC. ° MEKC yielded a higher amount of the cefotaxime dimer but a lower amount of an unidentified impurity with respect to LC. The differences may be due to the easier formation of the dimer in the aqueous sample solvent used in MEKC compared to the hydroorganic... 

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. 

International Conference on Harmonization Guideline on Data Elements for Transmission of Individual Case Safety Reports. This document s efforts focus on quality control/quality assurance endeavors to ensure accuracy and to promote validation in the handling of case safety reports for both preapproval and postapproval periods. It covers both adverse drug reaction and adverse event reports. 

Validation procedures, methodology and acceptance criteria should be specified in the analytical protocol, and/or the SOP. All experiments used to support claims or draw conclusions about the validity of the method should be described in a report (method validation report). Any modification of the method during the analysis of study samples will require adequate revalidation. The results of study sample determination should be given in the analytical report together with calibration and quality control sample results, repeat analyses (if any), and a representative number of sample chromatograms. 

The bioanalytical validation report (see section 6.7) should be attached. The bioanalytical report should include the data on calibrations and quality control samples. A representative number of chromatograms or other raw data should be included covering the whole calibration range, quality control samples and specimens from the clinical trial. 

Quantitative methods are assays that result in meaningful numeric measurements for a characteristic of a product. Quantitative methods are used in assessing whether final product meets specifications. They are also used to measure product quality (or quantity) in various stages of manufactuiing and the results are often used in quality control charts. Validation is an objective process used to determine whether a quantitative method is performing as expected and is appropriate for its intended use. This chapter provides the motivation behind validation, some terms and definitions used in validation, a consolidated statistically sound approach to validation, along with appropriate statistical analysis, and reporting of validation results. A hypothetical but realistic example is presented and is used to illustrate the validation process. 

Sweep, F.C., Fritsche, H.A., Gion, M., Klee, G.G., and Schmitt, M. (2003) Consider ations on development, validation, application, and quality control of immuno(metric) biomarker assays in clinical cancer research an EORTC NCI working group report. International Journal of Oncology, 23, 1715 1726. 

In cases where the matrix for calibration standards and quality controls (QCs) differs from the subject study samples, the use of a different matrix should be justified. Issues related to the use of a different matrix should be investigated during validation testing and described in the validation report. 

The SOPs should cover all aspects of the assay from the time the sample is collected and reaches the laboratory until the results of the bioassay are reported. A description of experiments concerning the validation conducted to determine variability, limit of quantification and the quality controls should be documented for data audit and inspection the traceability is a requirement for good analytical practice. Any deviations from SOPs should be documented with justifications for deviations. 

The methods used for laboratory testing of held samples should have validated performance and be conducted within a rigorous quality management system. To avoid reliance on poor data, great care is needed to ensure that the test results reported are derived from methods of known performance that have been applied exactly. This can be confirmed by ensuring that full validation and quality control information is available to support test data.14... 

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