Organization responsibilities

The second aspect of quahty documentation is to detail how the work processes referred to in the manual are performed. The QA unit is often the organization responsible for issuing a set of procedures designed to assure conformance to the appropriate standards or to company poHcy. The procedures, often called standard operation procedures (SOP) or quahty operating procedures (QOP), should include such topics as customer complaints, audit protocols, stabihty testing, preparation of COAs, test method vahdation, etc. 

Identification of the organization responsible for conducting each of the verification activities. 

Do enlist the support of the organization responsible for the problem to investigate the cause. 

As other cheaper materials usually give satisfactory performance, nickel and nickel alloys are not normally required for applications involving resistance to corrosion underground. Data on their behaviour in these circumstances are therefore sparse in particular, whether micro-organisms responsible for the accelerated corrosion of ferrous and other metals in certain anaerobic soils have any influence on nickel and its alloys, is uncertain. 

Stimulus-response coupling, another term for receptor coupling (see Receptor Coupling). It describes the series of biochemical reactions that link the initial activation of the receptor to the observed cellular (or organ) response. 

There is yet much to be done in establishing standards and objective methods in which one may have complete confidence. The frozen fruit and vegetable industry has developed rather rapidly during the past 20 years and it is now time for individuals and organizations responsible for the conduct of frozen food research to concentrate... 

There are several examples in which metabolites that toxify the organism responsible for their synthesis are produced. The classic example is fluoroacetate (Peters 1952), which enters the TCA cycle and is thereby converted into fluorocitrate. This effectively inhibits aconitase—the enzyme involved in the next metabolic step—so that cell metabolism itself is inhibited with the resulting death of the cell. Walsh (1982) has extensively reinvestigated the problan and revealed both the complexity of the mechanism of inhibition and the stereospecihcity of the formation of fluorocitrate from fluoroacetate (p. 239). It should be noted, however, that bacteria able to degrade fluoroacetate to fluoride exist so that some organisms have developed the capability for overcoming this toxicity (Meyer et al. 1990). 

In 1975 the World Health Organization produced a guideline for the establishment, maintenance and distribution of chemical reference substances (WHO 1975). This document was intended to foster collaboration and harmonization of approval for the provision of reference substances by national authorities and organizations responsible for reference substances collections. This guideline was revised in 1982 (WHO 1982) and a further revision was completed more recently (WHO 1999) to take into account progress in pharmaceutical analysis. The latest guidehne defines both primary chemical reference substance and secondary chemical reference substance as follows ... 

Describe the organism responsible for the majority of uncomplicated urinary tract infections. 

The quality manual shall provide a description of the structure of the construction organization. Responsibility, authority, and interrelation may be indicated by such means as organization charts, flowcharts, and/or job descriptions. These shall be included in the quality manual. 

The organization responsible for providing the NDE (VT, RT, UT, PT, or MT) shall be in compliance with ASTM E 1212 and ASME BPV Code Section V, Article 14 (Examination System Qualification). 

The task of interpreting the results of any of the animal-based bioassays must be considered from three different potential perspectives as to organ responsiveness. 

The penetration of light into and through dermal tissues has important consequences. This penetration is demonstrated in Fig. 11.1. Skin, as the primary organ responsible for thermal regulation, is overperfused relative to its metabolic requirements (Anderson and Parrish, 1981). 

The current structure of MedDRA is defined in Table 21.6. There will be a central maintenance organization responsible for development, user support, implementation and communication as well as an international user group. A management board will oversee the activities of the central maintenance organization with direction provided by the ICH Steering Committee. A standard medical dictionary will facilitate electronic data exchange between industry and regulatory authorities worldwide, as recommended by the ICH. 

Objectives Optimize biological activity of drugs Find new active lead compounds Characteristics Response in isolated systems Effects are specific and well defined Specific mechanism of action Receptor is known in most cases Techniques Hansch Approach Multivariate Analysis Computerized molecular modeling Estimate rates of fate processes Analyze Processes Whole organism response Net effects (mortality growth, etc.) Specific nonspecific mechanisms Receptor unknown in most cases Hansch Approach Multivariate Analysis Molecular modeling not applied... 

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