Good Laboratory Practices quality processes

Beyond the ROI issues, one of the premises for the use of advanced process analyzers is improved product quality. For many industries, and in particular industries close to consumers, there is the need to define procedures and installation qualification/oper-ational qualification/performance qualification (IQ/OQ/PQ) issues, good laboratory practice and good manufacturing practice (GLP/GMP), audit trails, etc. Such requirements open the door for the use of improved analytical methodology, which can be readily provided by the implementation of good process analyzer technology. 

On February 10 and 11 (1987, we) met in Geneva, New York and informally audited the Good Laboratory Practices (GLP s) and performed a Quality Assurance (QA) audit of. .. projects chosen at random. It was intended for the laboratory personnel to understand that the audit process would be helpful to their organization and also helpful to the. .. program. The entire staff of the Geneva labs participated in the process in a very cooperative and hospitable manner. 

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Adherence by test facilities to the principles of GLP ensures that there is a proper plan-... 

Closely related to preventive action is the process audit. Such an audit is performed as part of a laboratory assessment for each test on the proposed scope of accreditation. Performance of a test procedure is observed relative not only to the requirements of the ISO 17025 standard (or ISO Guide 25) but also with respect to performing the ASTM or ISO test method properly. As a minimum, the laboratory must have properly calibrated equipment, the current test method, and trained testing personnel. In addition, a representative number of test demonstrations will reveal whether good laboratory practices are observed in sample preparation, using the correct test parameters and calculating the results. When operators and technicians accept responsibility through such demonstrations, they tend to commit to the quality process. Real improvement occurs with involvement at all levels. 

Good Laboratory Practice (GLP) (U.K. DoH, 1995) GLP is concerned with the organizational processes and conditions under which studies are planned, performed, monitored, recorded, and reported in order to promote and maintain the quality and reliability of the test data generated. 

Assessment of contracted-out services, e.g. by storage and distribution agents, contract research organizations (CROs) and quality control laboratories for compliance with GMP, good clinical practices (GCP) and good laboratory practices (GLP), are further elements that may supplement the prequalification process. 

In this section we provide some practical considerations to chemists not familiar with the use of immunoassays for food contaminants. We focus primarily on the use of 96-well microtiter ELISA. Regardless of the type of sample and analysis, good laboratory practices (GLPs) and international standards organization (ISO) standards, where they apply, need to be followed to ensure the quality of results and the minimization of variability. Like any other analytical protocol, the analysis of contaminants by immunoassay is a combination of three sequential steps sample collection and preparation, sample analysis, and data processing followed by the interpretation of results. 

The process of method validation (i.e., evaluation of the assay) affects the quality of the quantitative data directly [9 A Guide to Analytical Method Validation, Waters Corporation]. Through method validation, it is assured that the method developed is acceptable. Issues involved in the validation of a mass spectrometry method for quantitative analysis are similar to those in any other analytical technique. The validation involves undertaking a series of studies to demonstrate the limit of detection G OD) limit of quantitation (LOQ) linear range specificity within-day precision and accuracy and day-to-day precision and accuracy, specificity, and robustness of the method. All of these parameters must be determined with those commonly accepted good laboratory practices criteria that are applicable in the vafidation of analytical methods. 

In study-based quality management systems, such as good laboratory practice (GLP) and good clinical practice (GCP), the study number is considered as the main index variable and any other information along the meta-data model can be derived from it. With the help of the meta-data model (see Box Meta-Data Model), it can be checked easily if the information of the documented GxP-relevant process is complete. 

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