General Quality Aspects

Experimental techniques for the characterization of drying processes and dried products have been presented in great detail in Volume 2 of this series. Additionally, several specific quality aspects of spray-dried powders have been discussed extensively in the foregoing sections of this chapter. This discussion will be conduded by brief reference to some less specific, general quality features ofvarious spray-dried products. 

Porosity of Spray-Dried Particles and Species Distribution 

The bulk density of a powder, which often is an important product quality aspect, depends, among others, on the inter-particulate porosity. The porosity of particle 

---

The trast within a business network is mostly based on logistics performance and general quality aspects that end consumers identify with a particular food. However, consumer behaviour is a combination of factors that is not within the scope of this chapter. Essential for the BtoB risk and trust process are supply chain management solutions through logistics strategies that show how supply readiness, product conditions, as well as the abihty to provide irrformation and the level of process documentation are achieved. 

The complex nature of SSP depends on many factors, all of which can affect the course of the reaction and the quality of the final product. An optimum combination of such variables thus determines the reaction process and needs to be discussed in detail. Therefore, some of the generally known aspects are reported in the following sections. 

The responses of main interest are different during both applications. In optimization, responses related to the separation of peaks (Section 6.2) are modelled. In robustness testing the quantitative aspect (the content determination) of the method is of most interest, since it is the one that should remain unaffected by small variations in the variables. Responses related to the separation (resolution, relative retention) or describing the general quality of the chromatogram (capacity factors, analysis times, asymmetry factors, and column efficacy) are often also studied. As recommended by the ICH guidelines the results of a robustness test can be used to define system suitability test limits for some of the responses [82]. 

The guide concentrates on the technical aspects of QA with emphasis on those areas where there is a particular interpretation required for chemical testing, and does not cover general quality assurance topics such as quality systems, reports, and record keeping. 

Experience has shown that the quality aspects for these greatly different processes are generally related to one or more of the ten fundamental rubber properties given below. 

Chapter 9 covers the quality aspects of laboratory operation in general, and much of this theory can be applied to any analytical method. Most laboratories will operate with at least some of the elements discussed in this chapter. 

For the drilling process, four main quality aspects have to be considered burr formation, dimension of bore, roughness, and errors in form. The drill milling leads in general to a lower burr formation... 

There is currently limited field experience with SSD for a smaller range of products. This database is expected to increase significantly in the coming decade. In the meantime, more pilot testing is recommended for the SSD application since the quality aspects are generally unpre-... 

It is the purpose of this book to describe the types of techniques now available to the polymer chemist and technician, and to discuss their capabilities, limitations and applications. All types of modern instrumentation are covered including those used in general quality control, research analysis, process monitoring and the mechanical, electrical, thermal and optical characteristics. Aspects such as automated analysis and computerised control of instruments are covered. 

Section 4 deals with requirements on topics relating to the management of safety, including quality assurance and verification of safety. This section covers the general safety aspects of nuclear installations and is based on IAEA safety standards and safety related publications [1,7-10]. 

An analytical laboratory or direct measurement facility should have a designated QA representative. This representative should monitor QC procedures, perform internal audits of the programme, and be responsible for training all personnel in QA, both in general terms and in the speeific quality aspects of their individual work. 

In order to quantify the sometimes intangible elements of variability associated with the product design and the safety aspects in service requires an understanding of risk . The assessment of risk in terms of general engineering practice will be discussed next. This will lead to a better understanding of designing for quality and reliability, which is the main focus of the book. 

The organization quality dimension. This is the extent to which the organization maximizes its efficiency and effectiveness, achieving minimum waste, efficient management, and good human relations. Companies that do not operate efficiently or do not meet their employees expectations will generally find their failure costs to be high and will lose their best people. This directly affects all aspects of quality. 

Previously, Chapter 2 examined the importance of the organisation, training and educational qualifications of personal as core elements of quality systems in general. Personal hy ene is a specific additional aspect that must be addressed to prevent the contamination of drugs. Training and practices must be adopted so as to achieve ... 

---