Quality assurance performance test

Inspections are not just an exercise which Quality Assurance performs for its own sake. Since it is the task of Quality Assurance to ensure the maintenance of GLP compliance, it is obvious that any deviations from the rules of GLP that are observed in these inspections should be corrected. Inspection reports therefore serve the dual function of permitting test facility management to judge the functioning of the Quality Assurance itself, and of permitting test facility management and Study Directors alike to institute the measures deemed necessary for a full and continued adherence to the GLP Principles. 

Testing must be performed in test laboratories which are approved by DIN-Certco. The approval is based on the ISO 17025 standard for quality assurance in test laboratories. 

As a first step in the direction outlined here some manufacturers and BAM last year discussed the problems and the possible procedures of such a system of quality assurance. As a result of this meeting round robin tests for the harmonization of the measurements of film system parameters and a possible procedure of surveillance of the quality of film systems were proposed. Closely related to these the BAM offers to perform the classification of film systems. But as during the production of films variations of the properties of the different batches cannot be avoided, the results of measurements of films of a single batch will be restricted to this charge, while only the measurements and mean of several batches of a film type will give representative values of its properties. This fact is taken into account already in section 4 of the standard EN 584-1 which can be interpreted as a kind of continuous surveillance. In accordance with this standard a film system caimot be certified on the base of measurements of a single emulsion only. 

Quality control is also the term used as the name of a department. In most cases Quality Control Departments perform inspection and test activities and the name derives from the authority that such departments have been given. They sort good products from bad products and authorize the release of the good products. It is also common to find that Quality Control Departments perform supplier control activities, which are called Supplier Quality Assurance or Vendor Control. In this respect they are authorized to release products from suppliers into the organization either from the supplier s premises or on receipt in the organization. 

This chapter illustrates the improvements in SEC column technology and modern applications of SEC separations. The better understanding of SEC column design and separation parameters described in the theoretical sections of this chapter will help the reader fine-tune his or her own work. The same is true for column performance tests, which should be applied regularly, especially after a column purchase. In order to obtain reproducible results, it is recommended to choose column manufacturers who can assure constant quality and performance and to invest in knowledgeable, well-trained support personnel and experienced application chemists. 

In-process quality control is the control exercised over starting materials and intermediates. Its importance stems from the opportunities that it provides for the examination of a product at the stages in its manufacture at which testing is most likely to provide the most meaningful information. The WHO Requirements and national authorities stipulate many in-process controls but manufacturers often perform tests in excess of those stipulated, especially sterility tests (Chapter 23) as, by so doing, they obtain assurance that production is proceeding normally and that the final product is likely to be satisfactory. Examples of in-process control abound but three of different types should suffice. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

Another external response to concerns about MCOs has been an increased interest in measuring the quality of care they deliver [35]. This interest has resulted in the development of numerous quality indicators. One example, HEDIS (Health Plan Employer Data and Information Set), is a standardized set of performance indicators used to compare health plans. Developed by the National Committee for Quality Assurance, HEDIS measures allow employers and employees to evaluate different plans. Only a small number of HEDIS indicators are related to medication use, but more drug-related indicators are likely to be added in the future. The use of quality indicators likely will increase as the measures become more refined and tested. 

This chapter deals with handling the data generated by analytical methods. The first section describes the key statistical parameters used to summarize and describe data sets. These parameters are important, as they are essential for many of the quality assurance activities described in this book. It is impossible to carry out effective method validation, evaluate measurement uncertainty, construct and interpret control charts or evaluate the data from proficiency testing schemes without some knowledge of basic statistics. This chapter also describes the use of control charts in monitoring the performance of measurements over a period of time. Finally, the concept of measurement uncertainty is introduced. The importance of evaluating uncertainty is explained and a systematic approach to evaluating uncertainty is described. 

The previous chapters of this book have discussed the many activities which laboratories undertake to help ensure the quality of the analytical results that are produced. There are many aspects of quality assurance and quality control that analysts carry out on a day-to-day basis to help them produce reliable results. Control charts are used to monitor method performance and identify when problems have arisen, and Certified Reference Materials are used to evaluate any bias in the results produced. These activities are sometimes referred to as internal quality control (IQC). In addition to all of these activities, it is extremely useful for laboratories to obtain an independent check of their performance and to be able to compare their performance with that of other laboratories carrying out similar types of analyses. This is achieved by taking part in interlaboratory studies. There are two main types of interlaboratory studies, namely proficiency testing (PT) schemes and collaborative studies (also known as collaborative trials). 

Materials purchased for the purpose of mixing with other materials in the preparation of pharmaceutical products are called raw materials. Pharmaceutical companies often purchase solid raw materials as powders in large drums. Quality assurance laboratories require samples of the material in the drums for the purpose of performing quality tests to see if the raw materials meet the specifications required for the company s products. 

Quality assurance unit Any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the (non-clinical laboratory) studies. 

Internal quality control is undertaken by the inclusion of particular reference materials, called control materials , into the analytical sequence and by duplicate analysis. The control materials should, wherever possible, be representative of the test materials under consideration in respect of matrix composition, the state of physical preparation and the concentration range of the analyte. As the control materials are treated in exactly the same way as the test materials, they are regarded as surrogates that can be used to characterise the performance of the analytical system, both at a specific time and over longer intervals. Internal quality control is a final check of the correct execution of all of the procedures (including calibration) that are prescribed in the analytical protocol and all of the other quality assurance measures that underlie good analytical practice. IQC is therefore necessarily retrospective. It is also required to be as far as possible independent of the analytical protocol, especially the calibration, that it is designed to test. 

Installation of fire water underground as early as possible Performance acceptance test Quality assurance inspections Emergency plan/drill... 

There are a number of quality assurance checks that should be considered before identifying the final list of causal factors. It is important to test for sufficiency of the information when compiling a sequence diagram. This test for sufficiency may be performed by asking one or more of the following questions, when comparing two adjoining facts in the sequence of events ... 

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