CONTENTS Quality Assurance

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

It can be concluded that, in the field of RM certification, NAA represents a major analytical technique contributing significantly to the certification of element contents in environmental and biological RMs, as was also pointed out earlier (Dyb-czynski 1980 1995), and also provides the bulk of the hterature data on NIST SRMs (Gladney et al. 1987,1993). NAA also has a similar position in the field of geological RMs (Roelandts 1991). It possesses unique quality assurance and self-verification aspects (Becker 1993 Byrne 1993 Byrne and Kucera 1997), though these in-built features are rarely exploited in fuU at present. It should be reahzed that the advanta-... 

Quevauviller Ph, Herzig R. and Muntau H (1996b) Certified reference material of lichen (CRM 482) for the quality control of trace element biomonitoring. Sci Total Environ 187 143-152 Quevauviller Ph, Lachica M., Barahona E, Rauret G, Ure A, Gomez A, and Muntau H (1997) The certification of the EDTA-extractable contents (mass fractions) of Cd, Cr, Ni, Pb, and Zn and of the DTPA-extractable contents (mass fractions) of Cd and Ni in calcareous soil by the extraction procedures given CRM 600. EUR Report 17555 Quevauviller Ph. Maier EA, and Griepink B, eds. (1995) Quality Assurance for Environmental Analysis. Elsevier. Amsterdam. 

Low Resolution Nuclear Magnetic Resonance (LR-NMR) systems are routinely used for food quality assurance in laboratory settings [25]. NMR based techniques are standardized and approved by the American Oil Chemist s Society (AOCS) (AOCSd 16b-93, AOCS AK 4-95), the International Union of Pure and Applied Chemistry (IUPAC) (solid fat content, IUPAC Norm 2.150) and the International Standards Organization (ISO) (oil seeds, ISO Dis/10565, ISO CD 10632). In addition to these standardized tests, low resolution NMR is used to measure moisture content, oil content and the state (solid or liquid) of fats in food. Table 4.7.1 summarizes common food products that are analyzed by low-resolution NMR for component concentration. 

Danzer K (1993) Information content of an analytical result and its assessment by interlaboratory studies. IDF Special Issue 9302 Analytical quality assurance and good laboratory practice in dairy laboratories. IDF, Brussels... 

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Quality Assurance Review. The Quality Assurance Branch assures that consistency across profiles is maintained, identifies any significant problems in format or content, and establishes that Guidance has been followed. 

The second edition CD-ROM contains 139 validation SOPs they are made available so that customers can input them into their computers and use their Microsoft Word programs to edit and print these documents. The contents of the procedures are written in simple and precise language to be in compliance with FDA regulation GMP and GLP requirements. The book ensures minimization of the number of documents to avoid the nightmare of the head of quality assurance at the time of FDA audit. The SOPs exclusively refer to the documents specially required for compliance however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. 

This decree takes into consideration the entire analysis environment necessary for quality assurance. Thus, it describes how the material organisation of a laboratory should be made, what the responsibility of personnel should be at every level of analysis as well as general rules regarding the content of a study and associated controls. 

Quality assurance functions primarily to monitor the fact that the quality function is being performed. Its role in PV is readily associated with its main functions. For example, it performs the tests that demonstrate the product s content uniformity. It may also perform the statistical evaluation of the test results to show that the process is reproducible. Quality assurance initiates the action to dispose of nonconforming product. It implements the inspection criteria and sets the specifications for product approval or rejection. It analyzes the product complaints to learn how effective its test program has been in preventing reject-able product from reaching the marketplace. 

The Analytical Laboratory staff should become involved in implementing the entire contents of the "Laboratory Quality Assurance Manual," as written, or change those criteria that are impossible or of no value. 

Twenty-eight of fifty-four samples purchased were found to have coatings made from polyester resins and so their contents were analysed for TPA and IPA. Analysis was by GC-MS after extraction and derivatisation to form the dimethyl esters of TPA and IPA. Included in the analytical quality assurance steps taken was participation in a check-sample exercise whereby four samples were supplied by a second laboratory and analysed blind. The performance of the testing laboratory was assessed from the accuracy and precision of their measurements and was demonstrated to be acceptable. 

The EPA Quality Assurance Project Plan Table of Contents... 

The successful IND is most likely a result of cooperative work with an integrated team represented by Regulatory, Quality Assurance, Clinical, CMC, and others. Quality Assurance, for example, is likely to have valuable input into the design of the Investigator s Brochure Clinical can contribute important direction and focus to the literature review Regulatory may have CMC input of value and so forth. The integrated team is more likely to both produce a smoothly integrated document and assure that the content of that document represents a cohesive and systematic assurance of public safety, which is the primary FDA focus. 

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