Quality and Testing

To support the development activities, accurate and sensitive analytical methods are required. With progress in development, increasing method validation work is performed and the acceptance criteria for drug quality and test method precision are tightened. 

As with traditional aseptic filling, in order to comply with pharmaceutical GMP, it is important to minimize contamination at all stages of manufacture. Raw materials should be of a high quality and tested for microbial contamination. Water used for product manufacture should be of low bioburden and high purity (preferably water-for-injection quality, although this requirement is dependent upon the nature of the product being manufactured). 

Technical Association of the Pulp and Paper Industry. (TAPPI). A professional group of scientists devoted to the interests of pulp and paper chemistry and technology. Founded in 1915, it has seven sections, each concerned with a specific phase of the industry. It also has 11 local sections that hold monthly meetings. The association publishes its own journal, as well as industry data sheets, bibliographies, technical monographs on subjects relating to the paper industry. It establishes standards of quality and testing procedures. The address is Technical Park, P.O. Box 105113, Atlanta, GA 30348-5113. 

This level of preformulation should be initiated in the beginning of the development cycle. The data consist of physicochemical properties of the chemical substance and analytical properties useful in the development of analytical methods, the evaluation of material quality, and testing for the acceptance of the formulation developed. In the early stage of development, the synthetic scheme is developed and the material available for preformulation may be limited. Thus the lack of supply quantities may affect the quality of data obtained. As the development cycle is pushed forward and the drug availability improves, data should be updated or refined with the use of more complicated and accurate methods. Part 1 of the preformulation report may be published before the establishment of specifications. The portion of this report consisting of analytical data may be known as an analytical profile in some organizations. 

More detailed information on the compliance requirements for the competence of calibration and testing laboratories is contained in ISO Guide 25. This guide has been interpreted to meet national requirements in some countries for example the UK Accreditation Service refers to it as UKAS MIO. Many laboratories seek accreditation to ISO Guide 25 and operate quality and testing systems which meet the requirements. The ISO Guide 25 approach heavily focuses on good analytical practices and adequate calibration of instruments with nationally or internationally traceable standards wherever possible. 

Standards for quality and testing of XT motors meet or exceed NEMA, NEC, IEEE, ANSI, and ASTM standards where applicable. 

Specifications and test methods for jet fuel. The specifications of jet fuels are set at the international level and are written into the Aviation Fuel Quality Requirements for Jointly Operated Systems". 

A specification or standard for product characteristics is valid only if it is matched with references to well defined and recognized test methods, such that quality control tests conducted by the parties involved —client and supplier, for example— are comparable even if they are performed at different locations. 

The basic condition of the Standard application - the availability of stable coupled probabilistic or the multiple probabilistic relations between then controlled quality indexes and magnetic characteristics of steel. All the probabilistic estimates, used in the Standard, are applied at confidence level not less than 0,95. General requirements to the means of control and procedure of its performance are also stipulated. Engineers of standard development endeavoured take into consideration the existed practice of technical control performance and test at the enterprises that is why the preparation of object control for the performance of nondestructive test can be done during the process of ordinary acceptance test. It is suggested that every enterprise is operated in correspondence with direct and non-destructive tests, obtained exactly at it, for detailed process chart and definite product type, however the tests have long since been performed after development of the Standard displayed that process gives way to unification. 

As reported before [Ref. 1], there are some essential parameters that influence the results of the testing, such as the thickness of the expired specimen, the quality and coarse grain of the built-in concrete, and the properties of the specimen-surface for the transducer s coupling. At the onset of testings none of tlrese parameters were available. As a result, we had to carry out preliminary investigations in order to prove the applicability of our testing-technique "in situ". 

The system has proven to be a powerful tool for inspections in the Nuclear industry with the potential of reducing the radiation doses for a highly qualified group of personnel and at the same time ensure a high quality and reproducibility of testing... 

FDA Quality Standards. Although standards for many dmgs and biologicals are included in the USP—NF, and for many food additives in the FCC, the FDA also estabhshes some specifications of its own. In the dmg field, specifications and testing methods for antibiotics and biologicals are set by the FDA. Also, specifications and testing methods are prescribed for colorants. Many food-additive petitions are granted with the requirement that certain specifications are met. 

Quality Control and Testing. Control of inks is done by examining their color strength, hue, tack, rheology, drying rate, stabiHty, and product resistance. Elaborate control equipment and laboratory testing procedures are employed to test the finished inks. Weather-Ometers,... 

Quality Spedfications and Test Procedures for Bottlers Granulated and Eiquid Sugar, National Soft Drink Association, Washington, D.C., 1975. 

Ceitification and records for components and materials. The examiner shall be assured, by examination of certification, records, or other evidence, that the materials and components are of the specified grades and that they have received reqiiired heat treatment, examination, and testing. The examiner shall provide the inspec tor with a certification that all quality-control requirements of the code and of the engineering design have been met. 

These tests should establish the optimum operating conditions, the ability of the dryer to handle the material physically, product quality and characteristics, and diyer size. The principal manufacturers of diying equipment are usually prepared to perform the required tests on dryers simulating their equipment. Occasionally, simple laboratoiy experiments can serve to reduce further the number of diyers under consideration. 

To eharaeterize the quality of test-system the notion relative width of UR region was suggested for the first time. The less the value of UR region relative width is the test-system the more tolerant to the random interferenees and better in analytieal sense. In the work the dependenee of LDC on the reaetion type, observation eondition of test-means staining, the earrier material type, UR region relative width and the number of observations was analysed. 

Some tolled products can be reworked if they fail quality assurance tests. In these cases the production cost may go up, but the product is not a complete loss. However, other tolled products, some pharmaceuticals for example, could be completely ruined by similar processing mishaps. Losses in these cases can be quite extensive. Test runs and approved rework procedures for such products may help avoid these losses. 

Philosophy of Quality Systems and Testing of Electrical Machines... 

Philosophy of quality systems and testing of electrical machines 11/247... 

Applicable to those who make their products on the basis of some proven designs, or work as ancillaries for standard products. ISO 9003 - Model for Quality Assurance in Final Inspection and Test. 

This is a test to monitor the quality and dielectric behaviour of the insulating system of high-voltage machines, 5 kV... 

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