Quality assurance internal

The daily checking should include leak testing of the equipment and the use of an internal standard. 

Once per day, the molecular masses that could indicate a leak should be checked. These are 18 (water), 28 (nitrogen) and 32 (oxygen). A high level of these masses indicates a leak in the system, e.g., at the interface between the GC and the MS. If a leak is not found by routine testing, it can lead to an increased background and consequently poor analytical results. In the worst case, it can result in destruction of the filament. 

5 = amitriptyline 6 = diazepam 7 = nordiazepam 8 = bromazepam 9 = flurazepam 10 = alprazolam 

The standard used here contains components representing various groups of drugs of abuse, e.g.  

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During the inspection, the inspector should proceed with particular emphasis on the critical points. This system guarantees that the internal quality assurance is oriented to the risks associated with the particular type of production. It is a preventive approach. The employees who identify with the organic objective , who are involved in the process and assume responsibility for it, are more careful, because they understand the sense of quality assurance and do not feel that it is an additional burden, impractical, bothersome, a mere formality and bureaucratic. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

M. Parkany (editor ), Quality assurance for analytical laboratories. Royal Society of Chemistry, Cambridge, United Kingdom, 1993 (Proceedings of the Fifth International Symposium on the Harmonization of Internal Quality Assurance Schemes for Analytical Laboratories held in Washington DC, USA, 22-23 July... 

Internal quality assurance provides confidence to the management whereas external quality assurance provides confidence to the client. They are planned activities designed to ensure that the quality control activities are being properly implemented. 

Harmonization of international quality assurance schemes for analytical laboratories. 

It is recommended that procurement agencies involved in any of the key activities of procurement develop and implement their own internal quality assurance systems on the basis of the Model, including the elements described and technical details specified. It is important to ensure that the system is adapted to reflect the activities of each speciflc procurement agency. The system should cover all aspects of the agency s activities and should be comprehensive enough to ensure that interrelated activities which impact on the quality of pharmaceutical products are linked. 

The actual training of the analysts at the receiving end of the methods is an area that has received considerable attention from regulatory authorities and internal quality assurance auditors. There are several options to certify analysts to perform the required test procedures. One possibility is to qualify individual analysts on each method, thereby creating a matrix of methods and analysts. Such an approach can become cumbersome as it would involve substantial documentation with respect to training records for individual analysts. Compliance liability could also result if an analyst who was not certified produced reportable GMP data. 

Internal quality assurance and control procedures are designed to guarantee the reliability of the results generated by the laboratory QA and QC ensure that the reported results contain the appropriate accuracy and precision through stringent monitoring of the analytical process, documentation of procedures and method validation. 

Before participating in interlaboratory studies the laboratory must have set-up all adequate internal quality assurance and quality control systems [7]. This also means that all basic investigations have been performed for possible mistakes, that these have been noticed and corrected. In other words the laboratory has validated the method to be applied. For a laboratory performance study, this also implies that in the laboratory the method is under statistical control for a given type of matrix, that this control is monitored and that results are evaluated. 

Internal quality assurance is concerned with maintaining precision within a single laboratory, where the importance of keeping careful records, based on reference materials and using appropriate control charts is well established. External quality assurance involves reference materials obtained from an outside body, and is a method for testing the bias of laboratory results. In practice, internal quality assurance mainly has to do with laboratory precision, whereas external quality assurance mainly has to do with laboratory bias (ISO 5725,1986). 

In this section, discussion is limited to suppliers of reference materials which are available internationally, i.e. we are concerned here more with external quality assurance than with internal quality assurance. This is not intended to minimize the importance of reference materials for internal quality assurance indeed these are essential for monitoring the precision of the analytical methods and for establishing statistical control, e.g. using control charts. 

Every analytical laboratory should have its own reference materials for internal quality assurance, and such materials should conform to the same standards of appropriateness, homogeneity and long term stability as are required for certified reference materials (see section "preparation of reference materials). In practice, however, most analytical laboratories do not use their own "in-house" reference materials for internal quality assurance but rather rely on internationally available reference materials. In the opinion of the present author, this is undesirable since much larger amounts are required for internal quality assurance than for externai quality assurance, and thereby the available stocks of expensively prepared certified reference materials will be consumed much too quickly. 

At a plasma/serum concentration of 0.98 mg/L, the within batch precision was found to be 2.1% (n = 48). Internal quality assurance is assessed by use of samples taken from a pooled collection of bovine serum, and the between batch precision is calculated monthly. Typical findings at a mean concentration of 1.14 mg Zn/L are an RSD of 1.8%. External Quality Assurance is by participation in a UK inter-laboratory scheme (Robens Institute. University of Surrey). 

For internal quality assurance, control samples are applied as... 

The first reason for such standards is to provide these guidelines. While each organization is different and thus has different needs for quality assurance, there are many elements that are fundamental to all organizations. These elements can be standardized and are found in such standards. This provides internal quality assurance. 

Many participants meant that the checklists were most suitable as an internal quality assurance to verify that aU relevant HF-aspects in a design solution were covered. Others meant that they were good for workshops as well. It was pointed out that the checklists needed to be adapted to the project type and current project phase in order to be used effectively. 

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