Quality management Good laboratory practic

The principles of Good Laboratory Practice (GLP) in conjunction with the principles of Total Quality Management (see chapter 6) ensure the quality and reliability of the laboratory results, which in turn help to ensure the protection of the environment and human health and safety. A step further is the accreditation of laboratories to ISO 17025 (see chapter 2) to perform specified activities. 

Good Laboratory Practice is a quality system that is tailored to the needs of the modem laboratories. Its principles are very close to the principles of the modem quality management systems like ISO 9000 and ISO 17025. However, GLP is specific to the non-clinical health and environmental safety studies, it covers physical and chemical test systems, and gives emphasis to biological test systems. It is of utmost importance to note that GLP principles were set out by the Organization for Economic Cooperation and Development (OECD) and after being modified they were adopted by the Emopean Union and are now the Commission Directive 1999/11/EC. 

Management has both directive and supportive responsibilities for the operations of the quality assurance unit to fully achieve compliance with Good Laboratory Practice regulations (1,2). The tone for the entire testing facility is set by management since it is their ultimate responsibility to establish and endorse procedures and policies which ensure a commitment to quality. 

Good Laboratory Practices (GLP) regulations insist on the appropriate management of animal data so that quality assurance/quality control (QA/QC) personnel can, at any time, select an animal number... 

In summary, four pillars support the structure of Good Laboratory Practice. All of them serve important functions in the context of performing and monitoring safety studies, and all of them need to be based on the strong conviction that GLP is the one mean to achieve quality data. Certainly, there are other aspects and issues in GLP that may be seen as nearly equally important, and they will be dealt with extensively further on, but Test Facility Management, Quality Assurance, Study Director, and National Compliance Monitoring Authorities are the key positions where real adherence to the Principles of GLP, not only by the letter but by the spirit of them, is determined in the end. 

Another very important responsibility of management is to ensure that there is a Quality Assurance Programme with designated personnel and furthermore to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice . As... 

As a final point to this section on inspections, it should be kept in mind that - as it is the case for any other operative procedures covered by the GLP Principles - the Quality Assurance Programme of inspections (and audits) should be subject to management verification. Management has to assure that the Quality Assurance responsibility is being performed in accordance with these Principles of Good Laboratory Practice which means that the Quality Assurance has to provide management with periodic reports on its activities, not only for single studies as already detailed above, but for the totality of its... 

Quality Assurance Programme means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these Principles of Good Laboratory Practice. 

The exact definition of good laboratory practice depends on who is defining it and for what purpose. A broad definition encompasses such issues as organization of the laboratory, management, personnel, facilities, equipment, operations, method validation, quality assurance, and record keeping. The goal is to certify that every... 

The method should be used in a laboratory with a quality management system that is in compliance with the ISO/IEC 17025 2005 Standard or with the Principles of Good Laboratory Practice. ... 

Use of the method must be embedded in an ISQ/IEC 17025 2005 Standard or Good Laboratory Practice Quality Management System and... 

Mr. de Jong is currently ITQA manager and is responsible for the quality system of the IT department of Solvay Pharmaceuticals in The Netherlands. He started his career in IT in 1978 as system specialist for Honeywell Bull, and joined Solvay in 1985 as a system analyst for the R D (research and development) automation center, especially within the Good Laboratory Practice (GLP) environment. He was involved in the translation of GxP guidelines to the IT world, in system development as well as system management. He is also member of Solvay s Computer Validation Committee. 

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