Analytical Test report

Method validation report of HPLG limit test for potential leachables from foil laminate overwrap, Analytical Test Report, Dey L.P., Napa CA., USA. 

Reports by the National Canners Association showed negative results on both taste tests and analytical tests for residual chlorides. Asparagus treated and canned in a manner comparable to the celery also gave completely negative results. 

The Student s (W.S. Gossett) /-lest is useful for comparisons of the means and standard deviations of different analytical test methods. Descriptions of the theory and use of this statistic are readily available in standard statistical texts including those in the references [1-6]. Use of this test will indicate whether the differences between a set of measurement and the true (known) value for those measurements is statistically meaningful. For Table 36-1 a comparison of METHOD B test results for each of the locations is compared to the known spiked analyte value for each sample. This statistical test indicates that METHOD B results are lower than the known analyte values for Sample No. 5 (Lab 1 and Lab 2), and Sample No. 6 (Lab 1). METHOD B reported value is higher for Sample No. 6 (Lab 2). Average results for this test indicate that METHOD B may result in analytical values trending lower than actual values. 

These last two points require that the analyst carefully consider the purpose of the volume measurement and whether it will directly affect the quantity of analyte tested, the numerical value to be reported. It is often true that volume measurements taken during such a procedure need not be precise even though the analytical results are to be precisely reported. 

Therefore, roles and responsibilities of the transfer exercise need to be discussed, clearly articulated, agreed and documented, including who does what and when. These roles and responsibilities should include availability of plant time (including shift cover), raw material testing time frames, OOS responsibilities and reporting, analytical testing time lines. 

Part II Part II is the report concerning chemical, pharmaceutical, and biological documentation. The report details the composition, method of development of formulation, manufacturing processes under GMP, analytical test procedures, bioavailability, and bioequivalence. It should be noted that all analytical test procedures need to be validated, and the validation studies must be provided. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

The larger part of the results reported in this paper, have been obtained with an old sample of a-titanium trichloride called a-TiCU—sample A. This sample is neither one of the most active nor one of the most stereospecific products we have studied. The analytical tests carried out on the product, have given the following results ... 

Measurement uncertainty is increasingly gaining attention, in particular in the framework of accreditation. The new accreditation standard ISO/IEC 17025 [17], which has been in force from December 2002 on, contains clear requirements on the estimation of MU and when and how it should be stated in test reports. ISO/IEC 17025 requires MU to be reported when required by the client and when relevant to the application and interpretation of the measurement results in the framework of certain specifications or decision limits. The MU should be readily available and reported together with the result as X U, where U is the expanded uncertainty [17, 47, 51, 54]. Also Eurachem and CCMAS within the Codex Alimentarius deal with MU as a separate issue [14,18-20]. Some even claim that MU will become the main unifying principle of analytical data quality [37]. 

A validation report is a written document that cross-references the validation protocol, summarizes the results obtained, describes any deviations observed, and draws the necessary conclusions, including recommending changes required to correct deficiencies for the qualification and validation performed [5]. In this report it is required to present both the results and conclusions and the secure approval of the study. The report should include a summary of the procedures used to clean, sample, and test as well as the physical and analytical test results or references for the same. The conclusions regarding the acceptability of the results should also be included. Other information would be the status of the procedures being validated, any recommendations based on the results, or any relevant information obtained during the study. These include, re validation practices (if applicable), the approved conclusions, and any deviations of the protocol that might have occurred. In cases where it is unlikely that further batches of the product will be manufactured for a period... 

NOTE Loss on ignition tests may be undertaken by different laboratories at temperatures ranging from 55Lower temperatures may be sufficient for the combustion of organic material, but may not always be for the complete decomposition of inorganic material. It is clearly important, in any analytical deposit report, to be able to differentiate between organics and inorganics and to be confident as to the quality of the result. 

In addition, analysis using the spectrometric techniques may reveal other chemicals relevant to the test. Unambiguous identification of a chemical is obtained if at least two analytical, preferably spectrometric, techniques give consistent results. Analyses are mostly qualitative (identification). Work is conducted according to the ROPs and other documented procedures of demonstrated performance. In the case of a PT, the testing report... 

ASTM distillation is a test prescribed by the American Society for Testing and Materials to measure the volume percent distilled at various temperatures.5 The results often are reported the other way around the temperatures at which given volume percents vaporize.8 These data indicate the quantity of conventional boiling range products occurring naturally in the crude oil. Analytical tests on each fraction indicate the kind of processing... 

Preformulation Report, Part I Physicochemical Properties and Analytical Testing for Drugs... 

Government agencies require accurate information and data recorded both in regulatory filings and in day-to-day operations of pharmaceutical manufacture. From a pharmaceutical laboratory s perspective, analysts need to ensure the accuracy and reliability of the data generated by their test methods. As shoAvn in Figure 2, there are required and fundamental controls that ensure the overall quality of the analytical test data. The interdependent processes represented in Figure 2 correlate to ensure the quality of the reported data. 

Modern software for the sample storage of all substances used in different analytical fields of QA of a corporation is of great interest for many customers and helps to solve logistics problems. A reference substance module stores information on substances for analytical testing (i.e., standard, reference, and impurities). This module includes support for ordering of the substances from the supplier and of the dispatch of analytical reports. 

Abramowitz M. Stegun 1., 1972. Handbook of Mathematical Functions. Dover Publ. N.Y. Carslaw H.S. Jaeger J.C. 1965. Conduction of Heat in Solids. Oxford Sc. Publ., Oxford. Claesson J. 2003. Drying and Resaturation of a Bentonite Annulus. An Analytical Solution. Report, Building Physics, Chalmers, Sweden. Rutqvist J., Noorishad J. Tsang C-F. 1999. Coupled Termohydromechanical Analysis of a Heater Test in Unsaturated Clay and Fractured Rock at the Kamaishi Mine. SKI report 99 50, the Swedish Nuclear Power Inspectorate. 

Virtually all analytical test methods require some form of calibration or verification before actual samples are analyzed. Different test methods require different calibration intervals. Thus, a decision about appropriate calibration fiequency must be made on a case by case basis. There is a tendency among many laboratories to do the bare minimum calibrations similar to their approach toward quality control requirements. This is not the way to achieve superior performance. Moreover, if an instrument is out-of-calibration, under no circumstances can data fiom that instrument be reported to the customers. 

These analytical tests are critical to establish the stability profile of APIs and drug products. These tests require a level of expertise and attention to detail that an experienced analyst needs. A training program is critical to ensure that the analyst understands the tests as well as recognizes the atypical or out-of-specification results. Proper reporting of results is also crucial for these procedures as some of them are subjective. 

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