Good laboratory practice compliance

All UK facilities conducting regulatory studies must be members of the UK Good Laboratory Practice compliance program and all regulatory studies must be conducted... 

Good laboratory practice compliance with respect to image acquisition and storage is considered to be achievable. 

U.S. Department of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs, Bioresearch Monitoring (BIMO), Good Laboratory Practice, Compliance Program 7348.808. 

Good Laboratory Practice Compliance Facility Inspection 21 CFR Part 58... 

WHY IS GOOD DOCUMENTATION AND A GOOD DOCUMENTATION SYSTEM THE KEY TO GOOD LABORATORY PRACTICE COMPLIANCE ... 

National) GLP Compliance Programme The particular scheme established by a Member country to monitor good laboratory practice compliance by test facilities within its territories, by means of inspections and study audits. 

National) GLP Monitoring Authority A body established within a Member country with responsibility for monitoring the good laboratory practice compliance of test facilities within its territories and for discharging other such functions related to good laboratory practice as may be nationally determined. It is understood that more than one such body may be established in a Member country. 

Components of Good Laboratory Practice Compliance Monitoring Procedures... 

Good Laboratory Practice Compliance Inspection Manual... 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

The characterisation of the toxicity associated with a specific chemical is invariably dependent on feeding the chemical to laboratory animals in statistically-based lifetime bioassay, guidelines for which have been agreed at the international level by the OECD (OECD, 1981) and the IPCS (IPCS, 1999), and which are undertaken strictly in compliance with the principles of good laboratory practice (GLP). The animals used in long-term bioassays are... 

Member States shall take all measures necessary to ensure that the laboratories referred to in Article 7 of Directive 89/397/EEC1 comply with the general criteria for the operation of testing laboratories laid down in European standard EN 450013 supplemented by Standard Operating Procedures and the random audit of their compliance by quality assurance personnel, in accordance with the OECD principles Nos. 2 and 7 of good laboratory practice as set out in Section II of Annex 2 of the Decision of the Council of the OECD of 12 Mar 1981 concerning the mutual acceptance of data in the assessment of chemicals.4... 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

As a tool to make mutual acceptance of risk assessments possible, OECD has developed the concept of Good Laboratory Practice (GLP). The OECD Principles of GLP are an integral part of the 1981 OECD council decision on the Mutual Assessment of Data (MAD) in the Assessment of Chemicals (revised 1997, Section 2.2.2). MAD also harmonizes procedures of GLP compliance monitoring, ensuring that preclinical safety studies are carried out according to the principles of GLP and that countries can have conftdence in the quahty and rigor of safety tests. 

Why do the laboratories need to demonstrate their competence and the reliability of their results Because they need to have competitive advantage and, at the same time, comply with legislation, where, more and more, reference is made to the need for reliable results and compliance with specific requirements (Accreditation, Good Laboratory Practice etc.)... 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

The Aimex I of the Directive 2004/9/EC consists of two parts Part A (Guides for compliance monitoring procedures for good laboratory practice) and Part B (Guidance for the conduct of test facility inspections and study audits). The provisions for the inspection and verification of GLP which are contained in Parts A and B are those contained in Annexes I and II respectively of the OECD Council Decision-Recommendation on comphance with principles of good laboratoiy practice. 

Guides for compliance monitoring procedures for good laboratory practice... 

A final report should be prepared after the completion of each laboratory activity. The final report should be signed and dated by the laboratory director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with the principles of good laboratory practice should be indicated. 

Applications for marketing should be sent to MHLW. The application then passes to PMDA, where the application splits into two different routes, namely (1) good laboratory practice (GLP), GCP and reliability compliance check by Office of Conformity Audit and (2) application review by Offices of New Drug or Office of Biologies. 

All pivotal studies, such as the main teratology study and any range-finding study performed to support the inclusion of women of childbearing potential in clinical trials, must be performed in compliance with Good Laboratory Practice. 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 42 Results of the Nonclinical Laboratory Good Laboratory Practices Pilot Compliance Program. Sept. 1977. 

Good Laboratory Practice 58.105(a) requires that all test articles be appropriately characterized. Compliance requires documentation that characterization has been done. The tests conducted to provide this documentation, however, are not GLP-regulated, although such tests wiU in many instances be subject to CGMP standards (e.g., when the test article will also be used in human clinical studies). 

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