Conformance testing

Conformance test procedure for instrument transformers (CTs and electromagnetic VTs)... 

Conformity test software Reports if a dossier on CD/ROM conforms to the CADDY format specification. Current version Revision 18, April 20, 1998. Freely available... 

Planned air washer, or humidification systems cleaning program (six monthly), to include washout, cleaning, disinfection, microbiological testing, and the issuance of a conforming test certificate. 

Positive tests Those that prove a certain condition exists (e.g., conformity testing)... 

Document IECEE 04 (1995) Rules and Procedures of the Scheme of the IECEE [the IEC System for Conformity Testing to Standards for Safety of Electrical Equipment] for Certification to Standards for Safety of Electrical Equipment for Explosive Atmospheres (IECEx-Scheme) followed by... 

In the drug-discovery field, chemists can use NIR to monitor the progress of reactions. Hearn and co-workers reported a NIR method to monitor the preparation of compounds for screening as antituberculosis drugs. The reaction of isonicotinic acid hydrazide (INH) with carbonyl compounds in the preparation of Schiff bases was followed. Forbes, Persinger, and Smith " described a NIR conformance test method to assay and identify two chemical intermediates used in the manufacture of Loracarbef, a carbacephalosporin. 

Forbes, R.A. Persinger, M.L. Smith, D.R. Development and validation of analytical methodology for near-infrared conformance testing of pharmaceutical intermediates. J. Pharm. Biomed. Anal. 1996,15, 315-327. 

Most manufacturers perform periodic tests on their products for total microbial counts and the presence of known problem microorganisms generally these are used for in-house confirmation of the continuing efficiency of their GPMP systems, rather than as conventional end-product conformance tests. Fluctuation in values, or the appearance of specific and unusual species, can warn of defects in procedures and impending problems. 

For Waste Water Treatment plans, STAC can monitor both influents and effluents. Same as natural water, STAC can monitor water pollution (COD, BOD, TSS, N03 ) and quality thanks to the conformity test. 

At this point, there usually follows a chapter about the pretreatment of the samples. However, in contrast to HPLC/GC, sample preparation for TLC is not considered to be quite as critical. As well as the use of precoated layers with a concentration zone (e.g. an application zone consisting of silica 50 000 and a separation zone of sihca gel 60 or RP-18 material) upon which the matrix constituents can often be held back by suitable choice of solvent system, a chromatogram that is imusable for lack of sample preparation is more rapidly rectified (use a different preparation method and a new plate ) than an irreversibly destroyed column. A detailed treatment of the subject of sample preparation would exceed the scope of the present book. In Section 9.4, rm-der the title Examples of GMP/GLP-Conforming Testing Procedures , we describe the extraction of a pharmaceutically active substance from a tablet and the working up of plant components from dry extracts. The reader is referred to other TLC textbooks [2,21] and to literature and brochures produced by manufacturers of articles for sample preparation [28, 29]. 

The assessment of component quality once the manufacturing process is partly or fully completed allows only for a measurement of product conformance and, if a problem is revealed, some remedial action. Limited conformance testing lacks the essential anticipation that prevents problems and does not merely detect them. Therefore, as means of controlling quality, this simplistic regime of QC is a very poor tool. 

This system of commercial QC trust should lead to the customer expending more effort in aiding/improving the supplier s quality system (through regular quality audits), and less on routine conformance testing. The supplier has to be aware that a substandard delivery, unknowingly accepted for use, can have serious implications for the customer s production efficiency, but more critical consequences on patient efficacy. 

If libraries are built containing several materials, a series of conformity tests can be carried out. This approach allows the testing of not just quality but also identification (Fig. 9.21). Figure 9.22 shows a real application of this approach with three types of lactose being shown to have distinctly different libraries, related to particle size. 

Therefore, the judgment matrix satisfies the requirements of conformance test, the weights can be accepted. 

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