Division (National) GLP compliance programmes

GLP compliance monitoring is intended to ascertain whether test facilities have implemented GLP principles for the conduct of studies and are capable of assuring that the resulting data are of adequate quality. As indicated above, Member States should publish the details of their (national) GLP compliance programmes. Such information should, inter alia:

• define the scope and extent of the programme.

  A (national) GLP compliance programme may cover only a limited range of chemicals, for example, industrial chemicals, pesticides, pharmaceuticals, etc., or may include all chemicals. The scope of the monitoring for compliance should be defined, both with respect to the categories of chemicals and to the types of tests subject to it, for example, physical, chemical, toxicological and/or ecotoxicological,

• provide an indication as to the mechanism whereby test facilities enter the programme.

  The application of GLP principles to health and environmental safety data generated for regulatory purposes may be mandatory. A mechanism should be available whereby test facilities may have their compliance with GLP principles monitored by the appropriate (national) GLP Monitoring Authority,

• provide information on categories of test facility inspections/study audits.

  A (national) GLP compliance programme should include:

  1. (a)

     provision for test facility inspections. These inspections include both a general test facility inspection and a study audit of one or more on-going or completed studies;

  2. (b)

     provisions for special test facility inspections/study audits at the request of a Regulatory Authority, for example, prompted by a query arising from the submission of data to a Regulatory Authority,

• define the powers of inspectors for entry into test facilities and their access to data held by test facilities (including specimens, SOPs (standard operating procedures) other documentation, etc.).

  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,

• describe the test facility inspection and study audit procedures for verification of GLP compliance.

  The documentation should indicate the procedures which will be used to examine both the organisational processes and the conditions under which studies are planned, performed, monitored and recorded. Guidance for such procedures is available in part B of this Annex,

• describe actions that may be taken as follow-up test facility inspections and study audits.