GB/T 22277-2008Advisory document for good laboratory practice -- The role and responsibilities of the sponsor in the application of the principles of GLP (English PDF)

4.1 Description

Although the GB/T 22278-2008 merely clarified the research part of the duties of the Principal, Principal and some unspecified level Responsibility, because this is in fact the principal is often initiated by one or more research, and the results will be submitted directly to the management of people. Principal should play an active role in the confirmation of all non-clinical health and environmental safety study whether the principles of compliance with GLP issues. Entrust Party can not rely solely on the guarantee contract testing organizations or institutions to implement these studies. Guidelines are given below describe the Principal shall fulfill it has a clear and undefined responsibilities.

4.2 Defining

Principal means an entity that commission, support and (or) to submit a non-clinical health and environmental safety studies (see GB/T 22278-2008 2.2.5.

Note 1. The Client may include.

Initiating a non-clinical health and environmental safety studies and provide support through financial or other resources of the entity.

Submit a non-clinical health and environmental safety studies to management, to register for the product or other needs in line with the principles of GLP support applications Entities.

Note 2. The "entity" may include one individual, partnership, business, association, scientific or academic institutions, government departments, or organizational unit in which, or on other legal Identifiable groups.

4.3 Liability of Principal

Principal shall understand the requirements of GLP principles, particularly those responsible for people involved in the testing facility managers and project/program on behalf of duties Claim.

NOTE. If you subcontract part of the study by the commission to the subcontractor, the client should understand the responsibility of the entire study is still borne by the person in charge of the project, including the original number According to the effectiveness and reporting.

4.4 When the health and environmental safety studies commissioned by a non-clinical time, the client should ensure that the testing facility to be able to follow the principles of GLP