Testing protocol summary

Representative test protocols, summary of digest-report investigation of two cases of reported flashback... 

Operating Guidelines The test protocol should be developed in consultation with the principal operators and supervisor. Their cooperation and understanding are required for the test to be successful. Once the protocol is approved, analysts should distribute an approved one-page summary of the test protocol to the operators. This should include a concise statement of me purpose of the test, the duration of the test, the operating conditions, and the measurements to be made. The supervisor for the unit should initial the test protocol. Attached to this statement shoiild be the tag sheet that will be used to record measurements. 

The medical records of the volunteers who received cholinesterase-reactivating chemicals consisted of the test protocol, physicians orders, nursing notes (Including clinical observations), a checklist of symptoms, and laboratory and performance test results. The reports of physicians examinations and physical findings were generally not Included. Volunteers were identified by number. The Committee on Toxicology s assessment was based on records and summaries provided by the Department of the Army and NRC staff. The procedures were described fully in Volume 1. In most cases, the analysis was based on summaries of drug administrations prepared by a consultant to the Panel. 

Protocol Summary. A summary of the protocol documentation. including an analysis of the test results, the compliance audit of the system, and any system modifications should be submitted to the computer systems validation committee for their review and approval. It is recommended that the system not be used until final validation approval is received from the committee. 

Representative test protocols, random-sample case report summaries... 

Clinical agreement >95% agreement of cotinine rapid test and reference method Clinical protocol summary... 

In summary, it is evident from the above discussion that although the CV testing system is more reliable than the CP testing systems for the determination of gas transport properties of hydrophilic films such as SPPO, the results from the former system also contain some element of uncertainty. Considering limited information on testing protocols followed in the measurement of gas permeation rates of films listed in Table 5, it is difficult to quantify this element of uncertainty in the reported values of SPPO permeabilities. 

In summary, the FT rheometry protocols described above and the associated data treatment yield a considerable number of information about the viscoelastic character of materials. Within less than 1 h, two samples are tested and the full data treatment is performed (using the present combination of VBA macros and MathCad routines). 

The physicochemical and other properties of any newly identified drug must be extensively characterized prior to its entry into clinical trials. As the vast bulk of biopharmaceuticals are proteins, a summary overview of the approach taken to initial characterization of these biomolecules is presented. A prerequisite to such characterization is initial purification of the protein. Purification to homogeneity usually requires a combination of three or more high-resolution chromatographic steps (Chapter 6). The purification protocol is designed carefully, as it usually forms the basis of subsequent pilot- and process-scale purification systems. The purified product is then subjected to a battery of tests that aim to characterize it fully. Moreover, once these characteristics have been defined, they form the basis of many of the QC identity tests routinely performed on the product during its subsequent commercial manufacture. As these identity tests are discussed in detail in Chapter 7, only an abbreviated overview is presented here, in the form of Figure 4.5. 

TABLE 14.4. Summary of Protocols Used for Current Test Methods... 

Summary The summary presents the case for the drug s approval. It includes discussion about the drug s mechanism of action, its effect on animals, results of clinical trials, manufacturing and tests methods, its stability, and proposed dosage and treatment protocol. The summary may run into hundreds of pages. It is one of the few documents being read by all the different reviewers as such, a good summary will assist with the review process. 

The newborn rat is a natural split-brain preparation for olfactory learning protocols it can be trained to associate an odor with a milk reward via just one nostril. If the other nostril is tested, the animal shows no preference. However, at 12 days of age or later, the two sides of the brain are connected and a learned preference occurs with either nostril open. The information is stored M/nlaterally the animal shows unilateral preference if the commissure is cut after training. The maturation of the commissure pathways occurs between 6 and 12 days of age. In summary, unilaterally represented memories remain unilateral, even after bilateral retrieval processes have developed. The mnemonic storage capacity of the brain is increased by confining memory to one side (Kucharski and Hall, 1987). 

Complete experiment records are available on 103 CS subjects (Table 4-18) a summary Is available on an additional 86 subjects who participated In CS skln-sensitlzatlon experiments In 1972. The records represent a cross-section of many of the CS protocols. The amount of Information In each record varies with the protocol. Ct s, where mentioned In the 105 records, ranged from 7 to 345 mg-min/m. Exposure times, where mentioned in the 105 records, ranged from 18 s to 10 min. In motivation experiments, subjects attempted to remain in CS for up to 200 s, but many left before test completion. Dosages In skin tests were 0.01 or 0.025 ml of 1Z CS applied to bare or clothed arms. 

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... 

Audit Report. A report of an independent audit of the computer validation process by an internal auditor (i.e. Quality Assurance) should be included with the summary report to management. The audit should compare the SOP and the initial parts of the protocol (what the system should do) with the test plan results (what the system actually does) and the summary report conclusions. 

For emissions testing to be accepted as a meaningful and necessary part of product quality assessment, relevant test methods must ensure acceptable uncertainty. Any associated products standards, incorporating pass/fail criteria, must also take into account the actual uncertainty of the standard methods specified. A relatively detailed summary of some of the major potential causes of error in the multistep materials emissions testing process is presented later in this chapter (see Section 6.6.2). For an emissions test standard/protocol to be robust and useful, it must take into account all of these issues and include sufficient guidance to ensure that a competent laboratory can achieve results within the expected uncertainty limits. 

The FDA s lot release regulations allow the agency to require manufacturers to submit samples of any licensed biological products for testing [24], Manufacturers must submit to CBER representative samples of each lot, a lot release protocol, and a summary of the test results. Lots may not be released until CBER authorizes an official release. However, CBER does not require lot release in all circumstances. 

The review of the protocol ensures that there are adequate selection criteria and procedures to protect vulnerable study populations. In addition, information within the protocol, the informed consent, and the Investigator s Brochure are reviewed to assess safety information that may affect subjects. Institutional review boards are empowered with the authority to approve or disapprove research activities that are covered by regulations, as well as to require modifications to secure approval. Informed consents will be reviewed to assure that all the information provided is in accordance with 21 CFR 50.25 the IRB may also require that additional information be provided to study subjects in a separate format, such as a patient information sheet. If this requirement is waived, a written statement may be given to the subject. If a very short window of opportunity exists to dispense a research treatment to avoid a devastating or fatal outcome, a waiver for this requirement may be requested. It is important to note, however, that the sponsor must clearly describe or define the situations that would require testing without administering a written informed consent. Also, provisions that will be made to obtain the consent from family members must be in place. This issue will be discussed in more detail in the section on informed consent. In summary, the following criteria are used by IRBs to approve research ... 

This appendix describes experimental animal and in vitro studies that are used to assess developmental toxicity and male and female reproductive toxicity from exposures to pesticides, industrial chemicals, and food ingredients. The testing of pharmaceutical agents is not described in detail here, but can be found in FDA (1994). A summary of the study types, protocols, endpoints and limitations is presented in Table D-l. A description of the manifestations of each type of toxicity and guidance on the interpretation of results from the studies also are presented. 

Like the case for steaming, there are a variety of procedures used for MAT evaluations, none of which follow the current ASTM protocol in all respects. A summary of procedures used within the industry is presented in Table 3. One unique observation for MAT testing is that testing philosophies in Europe tend to be different than the US. In Europe, MAT testing is characterized by short injection times, less that 25 seconds, giving rise to higher space velocities, usually greater than 30 Hr-1. 

Notifications or applications for clinical trials are supported by summaries or full reports on the preclinical pharmacology and safety assessment. The kind of safety data (e.g. the type and duration of toxicity tests), which are expected at this time, should correspond to the intended route and duration of application. Data on process details and on the quality of the product are not always required. But it must be kept in mind that clinical trials can only render useful results for the later product registration, if the quality characteristics of the tested product and its method of production are the essentially same as for the final product. If available, clinical data from trials in other countries must also be provided. Protocols for the intended clinical trials are an essential part of the application. 

Once the qualification protocols have been completed, test results and data need to be formally evaluated. Written evaluation needs to be presented clearly in a manner that can be readily understood. The report should also address any non-conformance or deviation to the validation plan encountered during the qualification and resolution. The outline of the report parallels the structure of the associated protocol. The qualification testing should be linked with relevant specification s acceptance criteria, such as PQ vs. system requirements specification deliverable, OQ vs. system specification deliverable, and IQ vs. technical design specification deliverable. If applicable, it is included as part of the summary of the results of inspections and technical review of all technologies that are elements of the systems. 

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