Test identity 228 - plan

The diagnostic test will help you identity your weak spots in the course. It is not designed to be a practice AP test. The questions may not resemble actual AP items. The purpose of the diagnostic test is to give you the opportunity to test your knowledge in a number of areas and, based on the results of this test, to plan your study time for the AP test accordingly. 

Testing must be conducted in a typical end-user environment, or in a simulated end-user environment, identical with the environment where the software/computer system will be used. Documentation of testing can be recorded as raw data, such as in a logbook, and should include the parameters tested, and the results of testing. The data should be tabulated as a final report document that includes all details included in the test plan, their execution, the results, and conclusions. The final report document must be signed by appropriate personnel, reviewed as needed, and archived. Upon successful completion of testing, the software/computer system can be released for testing and use in an actual end-user environment. 

The functional requirement specification (FRS) and its nearly identical twin, the user requirement specification (URS), is a list of functions and features the device should process. If there are specific needs the customer (user) has then this is the place to include it. The level of specificity may be dependent on the experience the end-user has with dissolution. An experienced dissolution scientist will be sensitive to issues such as cross-contamination or the importance of timing etc. Critical specifications need to be clearly stated since the FRS serves as the starting point of the test plan (discussed in the next section). 

The FDA s dehnition of comparability protocol is a well-defined, written plan for assessing the effect of specific CMC changes in the identity, strength, purity, and potency of a specific drug product as these factors relate to the safety and effectiveness of the product. A comparability protocol describes changes that are covered under the protocol and specifies the tests and studies that will be performed, including analytical procedures that will be used, and acceptance criteria that will be achieved to demonstrate that specified CMC changes do not adversely affect the product. ... 

If there are separate analysis plans for the clinical and economic evaluations, efforts should be made to make them as consistent as possible (e.g., shared use of an intention-to-treat analysis, shared use of statistical tests for variables used commonly by both analyses, etc.). At the same time, the outcomes of the clinical and economic studies can differ (e.g., the primary outcome of the clinical evaluation might focus on event-free survival, while the primary outcome of the economic evaluation might focus on quality-adjusted survival). Thus, the two plans need not be identical. 

The requirements for hardware validation are identical to those of any other equipment in use, comprising the OQ/IQ/PQ cycle, except that in the PQ, it is the test of software used. The software validation comprises functional testing, in which defined inputs produce outputs that meet expectations or specifications a thorough examination of source codes, database designs, programming standards, control methods, and support documentation or a quality-assurance program that includes alternate plans, contingency practices, record retrieval, and security practices... 

The diet was planned with a test breakfast to compare the availabilities of zinc, iron, and copper from browned corn products (corn flakes) with those from unbrowned corn products (hot corn grit cereal). The breakfast served for all 3 days of the menu cycle at all energy levels was identical, with only the... 

According to 21 CFR 211.160(b), Laboratory controls shall include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity. ... 

As with the quality control plan for the formulator described above, acceptance tests on adhesives should be directed toward assurance that incoming materials are identical from lot to lot. However, this plan should also extend to the receipt and control of incoming adherends and other materials used in the bonding process. 

After installation and qualification the instrument requires regular maintenance and calibration. The instrument should be maintained on a preventive maintenance plan and calibrated periodically according to a documented schedule. The schedule for preventive maintenance and performance verification/recalibration will depend on the instrument, its environment, and its function. The proposed U.S.P. chapter on NIR spectrophotometry [6] suggests that The purpose of instrument qualification is to assure that an instrument is suitable for its intended application and, when requalified periodically, it continues to function properly over extended time periods. Performance verification includes a validation based on a quality of fit to an initial scan or group of scans included in the instrument qualification.. . . With such testing, it is expected that reference standard spectra collected on a new or newly repaired, properly operating instrument should be identical to spectra of those standards collected over... 

In summary, the WRS and BRS produce process water, vapor to the BRS OTS, and secondary waste in the form of a solid cake for shipment to an offsite TSDF. It is planned that the BRS OTS filter cake will be analyzed for toxicity characteristic leaching procedure (TCLP) organics (volatile and semivolatile constituents) and metals. In addition, the filter cake is planned to be tested for free liquids to ensure the dewatering has removed liquids in accordance with land disposal restrictions (PMACWA, 2006).25 The BRS OTS is, for the purposes of this report, identical to the BTA OTS except that there are no iron sponge absorbers or condensate pumps. The BRS OTS produces prefilter, HEPA, and charcoal filter secondary wastes. 

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