Download Good Laboratory Practice: OECD Principles and Guidance for by OECD Publishing PDF

By OECD Publishing

This ebook unites the entire OECD records regarding solid Laboratory perform and compliance tracking, and, within the Annex, reproduces the 3 OECD Council judgements with regards to the Mutual reputation of information within the review of chemical compounds. It comprises the overseas criteria for caliber of non-clinical environmental, well-being and safeguard facts on chemical compounds and chemical items in a regulatory context-the OECD rules of fine Laboratory Practice-and aiding Consensus and Advisory records on their interpretation and alertness. The OECD suggestions files for governments on tracking compliance with the great Laboratory perform ideas also are incorporated. This ebook therefore provides the cutting-edge on sturdy Laboratory perform and compliance tracking.

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Extra info for Good Laboratory Practice: OECD Principles and Guidance for Compliance Monitoring

Example text

Such a list is necessary for planning QA activities and assessing the QA workload in the laboratory. As is the case for any other operative procedures covered by the GLP Principles, the QA programme of inspections and audits should be subject to management verification. Both the QA staff and management should be able to justify the methods chosen for the performance of their tasks. Quality Assurance inspection reports National GLP monitoring authorities may request information relating to the types of inspections and their dates, including the phase(s) of the study inspected.

Delegation to QA of tasks which are attributed to management in the GLP Principles must not compromise the independence of the QA operation, and must not entail any involvement of QA personnel in the conduct of the study other than in a monitoring role. The person appointed to be responsible for QA must have direct access to the different levels of management, particularly to top level management of the test facility. Qualifications of Quality Assurance personnel Quality Assurance personnel should have the training, expertise and experience necessary to fulfil their responsibilities.

They must be familiar with the test procedures, standards and systems operated at or on behalf of the test facility. 1. CONSENSUS DOCUMENTS Individuals appointed to QA functions should have the ability to understand the basic concepts underlying the activities being monitored. They should also have a thorough understanding of the Principles of GLP. In case of lack of specialised knowledge, or the need for a second opinion, it is recommended that the QA operation ask for specialist support. Management should also ensure that there is a documented training programme encompassing all aspects of QA work.

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