National Monitoring Authorities

With the guidance for inspections and study audits provided by the OECD documents, the national monitoring authority assumes the role of a Super-Quality Assurance , in the sense that it wiU inspect the adherence of test facilities to the GLP Principles in an analogous way as the individual Quality Assurance units do it for the single test facility. Indeed the OECD document presented in Appendix IV.II ( Revised Guidance for the Conduct of 

Laboratory Inspections and Study Audits ) may be regarded to serve as 

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In the last few years, another problem concerning the relations between different national monitoring authorities arose with the more extensive use by test facilities and sponsors of the possibilities to conduct multi-site studies. On the one hand, it thus appeared possible that a test site in one country engaged in multi-site studies sponsored by test facilities in another country would not be inspected by, and not be included in the monitoring programme of, the monitoring authority of its country, thus leaving its GLP compliance in doubt. 

National GLP monitoring authorities may request information relating to the nature and dates of Quality Assurance inspections. However, Quality Assurance inspection reports should not normally be examined for their contents by national monitoring authorities as this may inhibit Quality Assurance when preparing inspection reports. Nevertheless, national monitoring... 

The Government of India has established the National GLP Compliance Monitoring Authority (India GLP), adopting the OECD quality system of the principles of GLP, for inspection, monitoring, and accreditation of test facilities in India for conducting nonclinical and environmental safety studies. Currently, India enjoys the full member status of OECD for GLP. India is a member of the OECD Test Guidelines program. 

Currently 23 Indian laboratories have been accredited by the Indian national GLP compliance monitoring authority as per the provisions of the OECD Principles of GLP to conduct nonclinical health and environmental safety studies. The Indian system of GLP inspection, accreditation, and monitoring of test facilities was started in 2004 (India GLP). 

In 1989, the OECD Council adopted an Act on Compliance with Principles of GLP. This Act contains a Decision that member countries shall (1) establish national procedures for monitoring compliance with GLP Principles, based on laboratory inspections and study audits (2) designate national compliance monitoring authorities ( CLP inspectors ) and (3) require the management of test facilities to issue a... 

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. 

The second responsibility may again be seen as dictated by self-interest. Since the sponsor should commission a GLP-compliant study, it lays squarely in his responsibility to ensure that the test facility to be chosen for the conduct of the study should indeed be able to perform the study under the conditions of the GLP Principles. Furthermore the requirement that the study should be conducted under GLP should certainly be fixed in the contract between sponsor and the test facility, i.e. the CRO. However, for assessing the ability of a test facility to conduct a study in compliance with GLP, the sponsor would be ill advised to rely solely on the assurances of the test facilities contacted for the possibility to perform such studies. The sponsor should either monitor the selected CRO prior to the initiation of the study, or the respective National Compliance Monitoring Authority may be contacted to determine the current GLP compliance status of the test facility. 

As an aside Inspections by national GLP Compliance Monitoring Authorities will probably, in the majority of instances, belong to the category of expected inspections, which will result in all the accompanying side-effects Test facility personnel will be doubly on the alert for doing everything correctly and according to the relevant study plans and SOPs, folders with... 

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. 

Inspector A person who performs the test facility inspections and study audits on behalf of the (National) GLP Monitoring Authority. 

National) GLP Monitoring Authorities will have access to commercially valuable information and, on occasion, may even need to remove commercially sensitive documents from a test facility or refer to them in detail in their reports. 

Inspectors should have qualifications and practical experience in the range of scientific disciplines relevant to the testing of chemicals. (National) GLP Monitoring Authorities should ... 

While Inspectors will not normally wish to enter test facilities against the will of the facility s management, circumstances may arise where test facility entry and access to data are essential to protect public health or the environment. The powers available to the (National) GLP Monitoring Authority in such cases should be defined. 

Where no or where only minor deviations have been found, the (National) GLP Monitoring Authority may ... 

Where serious deviations are found, the action taken by (National) GLP Monitoring Authorities will depend upon the particular circumstances of each case and the legal or administrative provisions under which GLP Gompliance Monitoring has been established within their countries. Actions which may be taken include, but are not limited to, the following ... 

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