Manufacturing quality assurance test methods

Quality assurance is concerned with maintaining the quality of products to set standards. This embraces the control of incoming materials, the control of compounds produced, the control of manufacturing processes and guaranteeing as far as possible the quality of the final product. Quality assurance schemes utilise physical testing methods as a most important part of their system. In fact most of the standardised test methods are principally... 

This appendix provides definitions and a source of basic information about polymers and chemical products - their properties, the processes by which they are made, the test methods used to assess product characteristics and assure product quality, and the types of equipment and materials that rely on feedstocks for their operation or manufacture. In most of the definitions, certain words and phrases are in italics others are in boldface. Italics indicate that the term is defined separately under its own heading boldface indicates that the term is of key importance in the definition or that it is a commonly used alternative word or phrase being described. 

Over 200 completed consensus standards and selected sections of additional draft standards that are not yet complete have been incorporated into guidance documents for applications for conducting clinical trials with investigational devices and applications for permitting devices to be marketed. These guidance documents are widely disseminated by the CDRH to all interested parties. Other standards used by the CDRH, or which the CDRH has helped to develop, concern measurement or test methods, or support good manufacturing practices and quality assurance. 

The quality assurance program for manufacture of butter oil, or anhydrous milkfat (AMF), also focuses on the quality of the raw materials. Naturally, many of the same considerations apply to handling raw cream for AMF manufacmre that apply to butter, except that vacreation is not used. As it is stored under ambient conditions, care against oxidation is essential. Oxidation is perhaps the most important mechanism by which milkfat deteriorates in quality. As the oxidation reaction is autocatalytic (i.e., the products of the reaction act as catalysts to promote further reaction), the normal quality-control tests, peroxide value and free fat acidity, could give misleading results when applied to stored butter. Methods of deaeration have been developed that could reduce potential oxidation (74). 

Standard test methods that have been trialled, tested and approved by independent committees are the main methods accepted by government purchasing departments, manufacturers and quality assurance systems. Many traditional British Standards have been incorporated into International Standards (ISO) and European Norme (BS EN) standards for use throughout the world. The following list contains some of the important test methods for the chemical analysis of rubbers, plastics and other elastomers used in coated fabrics. 

Whereas readers are referred to these specific documents for details available on the Web site http //www.fda.gov/cder/fdama, some of the specifics are briefly mentioned here. The essence of this guidance emphasizes the importance of the overall quality assurance in manufacturing a PET radiopharmaceutical. All equipment and measurements used in the manufacture must be validated. The areas and hoods in which PET radiopharmaceuticals are manufactured must be run in a sterile condition. The personnel responsible for the manufacture must be well trained in the methodology, and an appropriate number of personnel are required in a production laboratory. Each step of the production must be verified and records must be maintained. The sterility and pyrogen testing of the finished product must be performed by appropriate methods. If a PET radiopharmaceutical is to be commercially distributed, appropriate containers and techniques must be adopted for safe shipments. 

Short-lived radiopharmaceuticals have to be manufactured, quality-tested, and dispensed within a short time, adding constraint on safety procedures. In order to comply with the strict requirements of GMP, special methods for synthesis and in process quality control have been developed, assuring high quality of radiopharmaceuticals, without actually testing sterility and apyrogenicity before dispensing the labeled product. 

The manufacture of sterile products is subject to special requirements in order to minimise risks of microbiological contamination, and of particulate and pyrogen contamination. Much depends on the skill, training and attitudes of the personnel involved. Quality Assurance bears a particularly great importance, and this type of manufacture must strictly follow carefully established and validated methods of preparation and procedure. Sole reliance for sterility or other quality aspects must not be placed on any terminal process or finished product test. 

In the manufacture of sterile products, it is not sufficient that the finished product should meet the requirements of the quality control. The method of manufacture is of particular importance. Low bioburden of starting materials should be assured, and during the manufacture, the manufacturing area, personnel equipment and intermediate products should be controlled by microbiological tests. 

Quality eontrol embraces the monitoring of incoming materials, the control of the manufacturing processes, and checks of materials and products produced, so as to ensure and maintain the quality of the output from the factory. Physical testing methods are important in this regime, and most of the standardized test methods are intended for quality eontrol use it is probable that the majority of tests carried out are undertaken in the first place for quality assurance purposes. However, this book is about testing and is not a quality eontrol manual, so discussion here is restricted to the quality control of the testing process. 

Quality Assurance Plan obtained will be able to meet the desired standards for Material of construction, methods of fabrication, stress relieving, various tests of the equipments at every stage of manufacture as required for safe and satisfactory performance. 

Test models should accurately represent the intended design, with manufacturing methods and quality assurance and quality control similar to that intended for the finished product. Increased emphasis should be placed on the prototype in order to ensure that a test specimen is a true representation of the product. If simulated radioactive contents are being used, these contents should truly represent the actual contents in mass, density, chemical composition, volume and any other... 

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