Good Laboratory Practice compliance monitoring

Components of Good Laboratory Practice Compliance Monitoring Procedures... 

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. 

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. 

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. 

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. 

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... 

OECD, Environment Directorate—Chemicals Group and Management Committee (1998), OECD series on principles of good laboratory practice and compliance monitoring, number 1 OECD Principles on Good Laboratory Practice (Paris Organisation for Economic Co-operation and Development). 

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1 OECD Principles on Good Laboratory Practice (as revised in 1997). Chemicals Group and Management Committee. ENV/MC/CHEM(98)17. 

US EPA. Toxic Substances Control, Good Laboratory Practice standards, Code of Federal Regulations, Title 40, Part 792, effective December 29, 1983. http //www. epa.gov/compliance/monitoring/programs/fifra/glp.html... 

US FDA. Compliance Program Guidance Manual, Program 7348.808, Chapter 48, Bioresearch Monitoring, Good Laboratory Practice, Completion Date 09/03/93. http //www.fda.gov/ora/compliance ref/bimo/7348 808/48-808.pdf... 

OECD. No. 2 Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice. http //www.olis.oecd.org/olis/1995doc.nsf/LinkTo/ ocde-gd(95)66... 

Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995). 

OECD Series on Good Laboratory Practice and Compliance Monitoring, Monographs 1-10, OECD, Paris, 1998. 

OECD (1992) Compliance of laboratory suppliers with GLP principles, Series on principles of good laboratory practice and compliance monitoring, No. 5 GLP consensus document, environment monograph No. 49, Paris... 

---