Testing and Acceptance

At the time of completion of an installation, the water and air conditions and the loads may not be exactly the same as those of the design specification. Acceptance tests performed then must be analyzed to determine if the performance is equivalent to that under the design specifications. Such tests usually are performed in accordance with recommendations of the Cooling Tower Institute. 

Williams-Gardner, Industrial Drying, Leonard Hill, Glasgow, 1971. Cooling Towers 

Cheremisinoff and P.N. Cheremisinoff, Cooling Towers Selection, Design and Practice, Ann Arbor Science, Ann Arbor, MI, 1981. 

Cooling Tower Institute, Performance Curves, CTI, Spring, TX, 1967. 

Foust et al., Principles of Unit Operations, Wiley, New York, 1980. 

Badger and J.T. Banchero, introduction to Chemical Engineering, McGraw-Hill, New York, 1966. 

Drying Principles and Practke, Pergamou, New York, 1972. 

introduction to Industrial Drying Operations, Pergamon, New York, 1978. 

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Pipes and Cole [2-25] measured the interaction term F,2 in various off-axis tests for boron-epoxy. They reported significant variation of F,2 for off-axis tension tests and acceptable variation for off-axis compression tests. However, compression tests are much more difficult to perform than simple off-axis tension tests on a flat specimen with a high length-to-width ratio. A compression specimen with a high length-to-... 

Manufacturing validation data, which should aim to identify the critical process steps, especially for nonstandard manufacturing processes such as for new dosage forms, should be discussed in the development pharmaceutics section of the application. Validation data may be accepted based on closely related products. In-process control tests and acceptance limits should be included for any aspect where conformity with the finished product tests cannot otherwise be guaranteed (e.g., mixing, granulation, emulsification and nonpharmacopeial sterilization processes). 

The calibration of all instruments of the installations is carried out by the calibraion service of the quality department, following the rules of that service. The computer programs used in the two installations are permanently tested by a program tested and accepted by the quality department. Errors or deviations are recorded and must to be evaluated by the quality department as given in directive (s). 

Table 5. Typical Analytical Testing and Acceptance Criteria for Different Types of Method Transfer (adapted from Raska et al., 2012)...

TABLE I Summary of Calibration Tests and Acceptance Criteria... 

Although this process is usually very expensive, slow, and labor-intensive, its benefits far outweigh the costs. These benefits include eased regulatory approval through clearly defined and supported release testing and acceptance criteria. Just as important is the ability to create a baseline relative to which changes to the production can be evaluated. 

Specification, Release — The combination of physical, chemical, biological, and microbiological tests and acceptance criteria that determine the suitability of a drug product at the time of its release. 

To address performance, the results of nonfunctionality tests are considered sufficient if the test and acceptance criteria are appropriate for the intended purpose. Tests described there are typically considered sufficient standards for establishing specified properties and characteristics of specified materials of construction or packaging components. For nonfunctionality tests, an applicant should provide justification for the use of the test, a complete and detailed description of how the test was performed, and an explanation of what the test is intended to establish. If a related test is available, comparative data should be provided using both methods. Supporting data should include a demonstration of the suitability of the test for its intended use and its validation. 

In-process testing and acceptance criteria Finished product testing and acceptance criteria Test method references Formulation... 

Installation and operational qualification work includes verification of temperature, pressure, and flow rates, instrument calibration, and thorough flushing of the entire system to remove oil, metal particles, and other contaminants. The type of testing and acceptance limits listed in the validation protocol may vary from firm to firm however, compressed air with product contact should be tested for such quality attributes as hydrocarbons, water vapor, and microbial content (typically less than 0.1 CFU/cu. ft.)... 

The specification writer must try to put into the specification the requirements that, if met, will provide the greatest likelihood of success. These requirements should be standard tests and acceptable test limits that are agreed upon by both the supplier and the user. The tests should be indicative of how the adhesive is used in production and how the finished joint is to be used in service. Tests that are not directly applicable to the specific application should not be included. Tests should not be used simply because they are standard test methods or have been used in the past. 

The cotton and rayon used as fillers in solid oral dosage form containers may not meet pharmacopeial standards, but through appropriate tests and acceptance criteria for identification and moisture content, their adequacy should be shown. For example, rayon has been found to be a potential source of dissolution problems for gelatin capsules and gelatin-coated tablets. 

Desiccants or other absorbent materials are primary packaging component. The components should differ in shape and/or size from the tablets or capsules with which they are packaged. Their composition should be provided and their inertness should be proved through appropriate tests, and acceptance criteria should be established. 

Cooling Towers 280 Water Factors 285 Testing and Acceptance 285 References 285... 

Software and computer system validation differ from hardware validation in that it is harder to specify absolute performance criteria and functional specifications for software and to define tests and acceptance criteria. There are many publications that deal with the validation of software and computer systems in one way or another. However, either they are not specific for the requirements of analytical laboratories or they are not specific to computers in the laboratory. 

Preservative effectiveness (scope of test and acceptance criteria)... 

In addition to the universal tests described earlier, specific tests and acceptance criteria should be included for particular new drug products. The guideline does not include in its scope all conceivable dosage forms, largely because of limitations of time and the need to recruit expertise in some of the more specialized dosage forms such as inhalation products and transdermal... 

The specification should contain the following tests and acceptance... 

The following tests and acceptance criteria are considered generally applicable to all new drug substances. 

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