Design review meaning

The standard doesn t require a procedure for Management Review and while it does require procedures for Design Control it does not specify that a Design Review Procedure is required. The phrases consistent with and in accordance with have the same meaning as both imply compatibility and agreement. If you restrict yourself to a literal interpretation of the standard, you need produce no more than 43 documented procedures - possibly less if some aspects do not apply to your business. You can combine several procedures in one document, the size of which depends on the complexity of your business. The more complex the business the greater the number of quality system documents. The more variations in the ways that work is executed, the larger the quality system will need to be. If you have a small business and only one way of carry-... 

For DQ (also referred to as enhanced design review) this means review of documented activities throughout the supplier s design, development, and build phases and can include FAT. This is followed by verification and testing of the computer system in its operating environment, under IQ, OQ, and PQ (see Fig. 2). 

Batch Number A designation by means of a distinctive combination of numbers and/or letters printed on the drug label, and elsewhere on its packaging that identifies the batch/lot and that permits the production history of the b t h, including all stages of manufacture and control, to be tra and reviewed. 

For the core LIMS, one must be careful not to be lulled into a false sense of security by the supplier s claim that the software is a standard product. What this usually means is that a set of software modules has been used in at least one or perhaps a few other LIMS installations. In this case, we must pose the question, "Is it really standard or in fact bespoke " The approach that should be taken to these "standard modules" is to determine if they are indeed standard (i.e., they are not revised to fit your LIMS application and have multiple applications for which references are available). If they are not standard, then confirm that the supplier has performed a Source Code Review or a suitable design review. If no review has been performed, the pharmaceutical manufacturer will need to make a value judgment on the risk this imposes (taking into account the results of the GLP assessment) and, if necessary, request that the supplier perform a Source Code Review as part of the project. 

Part V provides a description of the hazards, their identification, ranking and assessment, the means by which they are to be controlled, and the recovery mechanisms. The design reviews and audits carried out to identify and assess hazards are also described. 

Maximum usefulness and focus on end use. Remember that the PSM assessment phase is a means to an end the design and installation of a workable PSM system within your company. This means you may want to gather information that might otherwise not be included in comparable studies, audits, or reviews, e.g., data concerning resource allocations and requirements. If so, these considerations should be factored into both selection of your assessment method and the specific design of the tools you select. 

Several model systems related to metalloenzymes such as carboxypeptidase and carbonic anhydrase have been reviewed. Breslow contributed a great deal to this field. He showed how to design precise geometries of bis- or trisimidazole derivatives as in natural enzymes. He was able to synthesize a modified cyclodextrin having both a catalytic metal ion moiety and a substrate binding cavity (26). Murakami prepared a novel macrocyclic bisimidazole compound which has also a substrate binding cavity and imidazole ligands for metal ion complexation. Yet the catalytic activities of these model systems are by no means enzymic. 

The mechanical properties of plastics enable them to perform in a wide variety of end uses and environments, often at lower cost than other design materials such as metal or wood. This section reviews the static property tests. Chapter 5 provides more information on the meaning of these type data. 

Solid plastic wall thicknesses for most materials should be targeted to be below 0.2 in. and preferably around 0.125 in. in the interest of avoiding the above pitfalls. In most cases ribbing will provide a satisfactory solution in other cases sandwich structures or reinforced materials may have to be considered. As reviewed elsewhere when presenting the ideal target to meet the best design such as the thinner wall just reviewed, does not mean that a thicker wall can not be processed, etc. The thicker wall can be processed requiring closer process controls (Chapter 8). 

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