Procedural-related

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

Job Specific Job-specific topics include training on new or revised operating, safety and maintenance procedures related to the toll. It could include emergency response plan training or laboratory technician training as well if those procedures were changed. 

The various densification mechanisms at different temperatures can be modelled and displayed in HIP diagrams, in which relative temperature is plotted against temperature normalised with respect to the melting-point (Arzt el al. 1983). This procedure relates closely to the deformation-mechanism maps discussed in Section 5.1.2.2. 

Articles describing procedures related to the DIERS development of this entire subject have been published by some members of the DIERS group. These are referenced here, but to adequately describe the methodology requires more space than is suitable for this chapter. The detailed descriptions and illustrations in the noted articles can be most helpful to the potential user. 

Sec. 820.182 Device history record - Maintain the production records for each batch of devices Sec. 820.186 Quality system record - Compile or refer to location of general procedures relating... 

Principles and Characteristics Because of the limited selectivity of extraction, a chromatographic analysis is almost always needed. Recently, a fair amount of progress has been made regarding the front end of the total analysis procedure, namely the integration of sample preparation (this being the analytical bottleneck) and separation. The idea behind such systems is to perform sample extraction, cleanup and concentration as an integral part of the analysis in a closed system. Scheme 7.2 shows the main procedures related to sample preparation for chromatographic analysis. 

Scheme 7.2 Main procedures related to sample preparation for chromatographic analysis...

The following procedure relates to electrophoretic protocols where the first dimension is developed by isoelectric focusing (in tube gels) and the second dimension is a size exclusion separation by SDS polyacrylamide electrophoresis in a slab gel. 

In 1993, a significant advance in simplifying the procedures relating to drug marketing authorization applications in the EU was made. At that time, the legal basis of a new drug approval system... 

A 2-Dimensional experiment is done to determine if there are any TLC artifacts, or what are known as TLC procedure-related effects. In this study, a spot of drug substance at nominal concentration, usually 25 mg/ml, is placed on the HPTLC plate by making one spot by overlaying 3 applications of 5 pi each. This yields one tight spot that contains 15 pi of drug substance solution, rather than a large spot that pools by performing one application. The HPTLC plate is then developed in the usual manner and dried. The plate is then rotated 90° and a second... 

Vander Heyden, Y., Questier, R, and Massart, D. L. (1998). A mggedness test strategy for procedure related factors experimental set-up and interpretation. /. Pharm. Biomed. Anal. 17, 153-168. 

GUIDELINES ON COMPANY PROCEDURES RELATING TO THE CODE OE PRACTICE LIST OF LEGISLATION, OTHER CODES GUIDELINES... 

The guidelines on company procedures relating to the Code which are on page 40 give further information on certification. 

Powers, S.W. (1999) Empirically supported treatments in pediatric psychology procedure-related pain. / Pediatr Psychol 24 131— 145. 

From the definitions given above it can be seen that there are two approaches to ruggedness testing (also equal to levels 1 and 2 given in the Acceptable Methods document [14]). In the first approach factors to be examined are selected from the set of operating and environmental conditions that are or could be stipulated in the analytical procedure. This kind of factors can be called procedure related factors. 

In the second approach non-procedure related factors are considered. Factors such as e.g. different laboratories, different analysts, different instruments, different lots of reagents, different days, different columns for HPLC methods or different plates for TLC methods are then examined. 

In the literature, ruggedness tests concern mainly procedure related factors, but occasionally one of the other factors, e.g. a column factor in HPLC, is examined. This will be discussed further in more detail (see Sections 3.4.2 and 3.4.4.4). The examination of the non-procedure related factors in ruggedness testing is described less frequently and requires another approach than the examination of procedure related factors. 

In Section 3.4 the strategy and the different possibilities for performing a ruggedness test when mainly procedure related factors are examined will be reviewed. In a later part (Section 3.5) ruggedness testing of nonprocedure related factors will be discussed. 

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