Quality control staff training

Identihcation of computer systems Defined specifications for computer systems Control procedures for software programs Security access on computer systems Archiving records Quality assurance Staff training... 

All relevant quality control staff should be suitably educated, trained and motivated to perform their tasks adequately. 

Lease negotiations were concluded and MACCS was installed on the MSDRL VAX in November, 1984. A few project files were generated from CSIS. These provided opportunities to refine the CSIS conversion programmes and develop quality control procedures. Four chemists were hired and trained for the quality control work, and the database conversion began in the second quarter of 1985. CSIS records were converted in blocks of 6,000 records each and in L-number order. The L-numbers from each batch that failed to generate a connection table were saved in a separate file. A CSIS structure print and the corresponding MACCS plot were manually compared by the quality control staff for each record that was converted. Approximately 30% of these required some correction to the structure diagram and/or the text data. 

Training for the staff of the companies on the concept of ChL. It is recommended to include staff from the environment and quality control department, the purchasing department, the legal department (if any), technical and operational staff, and others. 

The responsibilities for suitable validated analytical methods, however, do not rest solely in the analytical method development group. Today the analytical function uses new and sophisticated chromatographic and other instrumental techniques that require a high level of technical expertise. It is the responsibility of quality control management to ensure that its staff is adequately trained and its laboratories properly equipped so that new analytical methods can be properly transferred from an analytical methods group to the quality control department. A mutual understanding of each other s responsibilities and limitations is... 

Quality System (including status of required computer validation/revalidation, change control, and training/qualihcation of QA staff)... 

Everything should be normalized process controls, equipment servicing, staff training, quality control (few indicators on critical points), frequency of the process review, and definition of responsibilities. The documentation of these activities should also be normalized. ... 

In addition to the mass spectral aspects of these assays, which are outlined below, there may also be extensive requirements to be met by the analyst with respect to compliance with good laboratory practice, which governs the operations of analytical laboratories and includes sampling regimes, assay validation procedures (e.g., limits of detection, limits of quantification, accuracy, reproducibility, and ruggedness), and laboratory accreditation (e.g., staff training, laboratory equipment, documentation, quality assurance, and quality control).142-145... 

At present there is no universally accepted Standard Method for Preparation of Samples from Contaminated Sites and few laboratories operate strictly comparable sample preparation methods. So it is important that the methods used for initial sample preparation are verifiably/// for their analytical purpose and applied by trained staff under an appropriate level of quality control. The design of sample preparation methods is generally constrained by the need to produce powders or finished samples with uniform physical characteristics by the most rapid method, whilst preventing the loss or alteration of any part of the sample by contamination, cross-contamination or chemical reaction. 

Although it is likely that the number of staff involved will be small, there should be separate people responsible for production and quality control. All production operations should be carried out under control of a clearly identified responsible person. Personnel involved in release of investigational medicinal products should be appropriately trained in quality systems, GMP and regulatory requirements specific to these types of products. They must be independent of the staff responsible for production. 

The personnel assigned to the operations of taking samples must be under the authority of the person responsible for quality control. The operations of withdrawing samples make special demands on the recruitment, selection, knowledge, motivation and training of the staff who must be trained and made aware of the importance of their role. They must be motivated and aware that sampling is a precision technique in the same way as analysis and that steps must thus be taken to do it meticulously. 

In order to achieve reliable results, Quality Control laboratories should have sufficient resources and appropriate facilities, with properly trained, managed and motivated staff, and adopt good quality control laboratory practices. Materials and products should not be released for use or supply until their quality has been judged satisfactory. Quality Control should be independent from Production. Quality Control should adopt procedures necessary to ensure that the relevant tests and checks are carried out... 

All Production, Quality Control and Laboratory personnel and all other personnel (e.g. maintenance, service and cleaning staff) whose duties take them into manufacturing areas, or which bear upon manufacturing activities, should be trained in the principles of Good Manufacturing Practice and in the practice (and the relevant theory) of the tasks assigned to them. 

The first article is from the plenary lecture given at the symposium by the symposium chairman Kishore Nadkami, It covers total quality management practices advocated for obtaining a perfect analysis. Proper staff training, sampling, calibration and quality control practices, adherence to test method details, participation in proficiency testing, accreditation from national bodies, benchmarking, etc., are some of the critically important approaches that need to be taken to achieve the ideal state of analytical Zen perfection. 

Quality assurance (QA) refers to the planned and systematic actions and measures that the laboratory uses to ensure the quality of its operations. These measures include, amongst others, implementation of a quality system, a suitable infrastructure and laboratory environment, appropriately trained and skilled staff, calibrated and well-maintained equipment, quality control procedures. 

Before attempting to start the plant, all the in-process quality checks must have been defined, methods agreed for various analyses and what corrective action is to be taken if a result is outside the desired range. Equally important is to check that laboratory staff have been trained and are kept advised about when to expect the first sample from the plant. If there is serious doubt about any a.spect of quality control, it should be cleared up before the plant is started up, in just the same way as if it were a problem with a piece of process equipment. 

For a greenfield site the quality control, analytical laboratory and microbiological laboratory have to be fully proven before main plant commissioning takes place. The precommissioning should be done by the future laboratory staff, assisted where necessary by the commissioning team. In a foreign location this calls for early recruitment of staff and their training. 

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