Standard format 243 - quality

The standard requires quality planning to be documented in a format to suit the supplier s method of operation. 

Establishes criteria for low to high concern using a minimum data set. A standardized format for the summary would comment on the sufficiency and quality of data to draw conclusions. 

Many importing countries require proof of registration of medicinal products in the country of origin before sales are permitted. To assist local manufacturers with export markets, the National Pharmaceutical Administration issues Certificates for Exporter of Medicinal Products to holders of product licences whose locally manufactured products conform to required standards of quality (See Appendix 7). The WHO format is used. 

The final component of the project involves correlating the analytical data with clinical information obtained by the contributing physicians. This could provide new insights regarding the role of oxysterols in the pathogenesis of atherosclerosis. Because specimens will be acquired from a variety of sources, a standardized format or questionnaire would be used to normalize the quality of the clinical information obtained from the different sources. 

The user-customised software approach places the responsibility on the customer for the creation of an integrated system through the availability of software tools such as subroutine libraries, built-in procedural programming languages, and standard formats for file export and inport. The success of this approach is dependent on the software development resources available locally and the quality of the customisation tools provided with each package to be integrated. 

Aim of the data retrieval stage is to extract all relevant raw data from their respective sources. The user is usually able to execute these workflows as they are and has nothing to care about the technical details of the various data sources. Test results for biological activity can be retrieved in standardized format from the corporate compound database (CDB, cf. Section 13.2.1). Other data, such as the BioProfde (cf. Section 13.3.2), the library information for compounds originating from combinatorial soeening hbraries or hit quality check results have to be retrieved directly from different laboratory information systems or from the CIDB(cf. Section 13.2.2). Once all the relevant data have been retrieved, it is stored conveniently as a set of files. This easily accessible collection serves as foundation for all subsequent analyses. 

It is impossible to describe a standard format for the organization and contents of a given report. High-quality well-written reports contain, however, the following common components ... 

It is not realistic to specify a standard format for a Quality Control Program prescribing a fixed number of monitoring devices such as Settlement Markers, Cone Penetration Tests, Plate Load Tests, Zone Load Tests, etc. for land reclamation projects. Lor the definition of such a program it should be realised what has to be monitored and, in particular, why it is to be monitored. The main goal of quality control is to verify whether the specified dimensions of the reclamation and the quality as well as the performance requirements of the fill mass are satisfied. Examples of aspects that need monitoring in land reclamation projects using hydraulic fill material are presented below ... 

A new project on electronic publishing, financially supported by the German Ministry of Research, and worked out by Wiley-VCH/Chemical Concepts, uses JCAMP and MDL standards (Figure 1). Spectroscopic data acquired directly from the spectrometer site are converted to the JCAMP format. The software TranSpec allows structure input or import in Molfile format. Quality control modules check the reliability of the information. The files in JCAMP and MDL formats are sent to the data server by email. Special software extracts the data from the email automatically and handles the entry into the database. 

To provide for the first point, a set of so-called manufacturing PRocess Information MAps (PRIMAs) have been developed. In a standard format for each process, the PRIMAs present knowledge and data on areas including material suitability, design considerations, quality issues, economics and process fundamentals and process variants. The information includes... 

This section discusses standard PCB technology and the influence various factors, (Table 3), a printed circuit board has on the overall solder joint formation process. Additionally, the components being placed onto the PCB can change the required technology used to fabricate the PCB and thus influence the solder joint formation quality. The components sub-group assembly parameters that can influence solder joint formation and subsequent reliability are shown in Table 4. 

Scientific, and especially chemical, information is becoming increasingly available on the Internet. This has the advantage that the information is accessible to other users. Additionally, the data formats (HTML, PDF, GIF, etc.) that are used are restricted to the most important ones to provide standards that are readable worldwide. Unfortunately, however, much of the information on the Internet is not reviewed or verified by other organizations as is the case in the primary literature. Thus, the quality of the information is extremely variable. 

Raw data must be analyzed and transformed into a format useful for specific purposes. Summary tables, graphs, and geographic distributions are some of the formats used for data display. Air quality information often consists of a large body of data collected at a variety of locations and over different seasons. Table 15-3 shows the tabular format used by the California Air Resources Board to reduce ozone hourly measurements to a format which shows information about compliance with air quality standards (6). The format has location, maximum values, annual means, and number of occurrences of hourly values above a given concentration as a function of the month of the year. One can quickly determine which areas are violating a standard, at what time of the year elevated concentrations are occurring, and the number of good data points collected. 

Although the standard does not specifically require a quality planning procedure, to ensure that such planning is carried out in a manner which avoids conflict with existing practices and in a format which suits your operations, you will need to prescribe the method to be employed in a procedure. Some contracts may stipulate a particular format for contract-specific procedures, especially when they are to be submitted to the customer for approval. If these procedures are only used by the project team, this may not cause any conflict. However, if they are to be used by staff in the line departments, you may have to reach a compromise with the customer so that any differences in format do not create implementation problems. 

During the sulfation of alcohol ethoxylates the undesired byproduct 1,4-di-oxane may be formed. Although the formation of 1,4-dioxane is predominantly governed by the sulfation and neutralization conditions and by the chemical composition of the organic feedstock, other factors, such as the quality of the raw material, also contribute. This prompted a reappraisal of the required quality standards for this feedstock. In Table 11 guideline specifications are presented. 

A long and difficult task will be confronted, in particular to bring ozone within the air quality standards, as the physics and chemistry of ozone formation in the MCMA are not sufficiently understood. 

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