Statistical good manufacturing practices

SAP superabsorbent plastic SGMP statistical good manufacturing practices... 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Good manufacturing practices (GMP) are essential in medical extrusion and involve both a high level of sanitation and process reproducibility. Process reproducibility can be quantified with statistical techniques that have been developed in the field of statistical process control (SPC). Therefore, SPC is a necessary requirement in medical extrusion [107]. GMP also requires full documentation and traceability. With respect to medical extruder machine design, the following aspects are of great importance ... 

Cliff N. 1993. Dominance statistics Ordinal analyses to answer ordinal questions. Psychol Bull 114 494-509. FDA (Food and Drug Administration). 1996. Current good manufacturing practice, quality control procedures, quality factors, notification requirements, and records and reports, for the production of infant formula. Proposed rule. Fed Regist 61 36153—36219. 

Select a total QC strategy to provide an appropriate balance between statistical and nonstatistical QC procedures. With 90% error detection, depend on the statistical QC component and perform the minimal preventive maintenance, instrument function checks, and method validation tests required by good laboratory practice, manufacturers instructions, and regulatory and accreditation guidelines. 

After a product or a process has been appropriately evaluated in terms of its usefulness and adequacy in the manufacturing operation the evaluation of the resulting product in terms of its acceptability to the consumer remains to be done. This also should be done with the aid of statistical methods, since there is at present in many cases no substitute for the subjective evaluation of a quality attribute of a food product. Where they exist, objective methods are usually used in conjunction with subjective methods in an effort to correlate them, with a view to the ultimate use of the objective method as a simple and inexpensive index of the quality of the product in question. In terms of research, however, in many cases this may not be done because no objective methods of evaluation exist. A good example concerns the evaluation of the flavor of a food product where, with practically no exceptions, subjective evaluation must be used. 

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