PART II - IMPLEMENTATION
This program provides for the inspection of public, private, and government nonclinical laboratories that perform testing on food and color additives, animal drugs, human drugs and biological products, human medical devices, diagnostic, and electronic products. Assignments for the initial GLP inspection of a specific university department or government facility are to be initiated only after the facility has been informed of the agencys intent to inspect by a letter from the Bioresearch Monitoring Program Coordinator (HFC-230). Notification of subsequent inspections of these laboratory facilities is not necessary. Consulting laboratories, contractors, and grantees are covered by the GLPs to the degree that they provide data for a nonclinical laboratory study. The sponsor or person contracting the service must notify them that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part. The consulting laboratory, contractor, or grantee Is only required to comply with those parts of the GLPs that are appropriate to the nature of their contributions to a study. FDA Centers or ORA headquarters will initiate all nonclinical laboratory inspections. Surveillance inspections are periodic, routine determinations of a laboratory's compliance with GLP regulations. These inspections include a facility inspection and audits of on-going and/or recently completed studies. Directed inspections are assigned to achieve a specific purpose, such as: Team inspections may be conducted. A field investigator will serve as team leader and is responsible for the cooperative conduct of the inspection. Responsibilities of the team leader are explained in the Investigations Operations Manual (IOM) 502.4. Field analyst or headquarters participant will serve as scientific or technical support to the team leader and shall participate in the inspection by: Any difficulties involving field analysts or headquarters participants in the inspection should be discussed with District management and, if not resolved, immediately referred to the HFC-130 contact for this program. Joint inspections with other government agency personnel may be conducted under this program. In all instances, the FDA field investigator will serve as the team leader. Specific instructions for conducting EPA data audits are provided in Compliance Program 7348.808A. All inspections of commercial laboratories are to be conducted without prior notification unless otherwise instructed by the assigning Center. Arrangements to conduct the initial inspection of university and government laboratories should be made soon after the laboratory has received the notification letter from the Bioresearch Monitoring Program Coordinator. Alert the Bioresearch Monitoring Program Coordinator to facilities that are becoming operational under GLPs. Notify the Center contact identified in the assignment when an inspection has been scheduled (preferably a week or more prior to the start of the inspection) or of any significant delay or postponement of an inspection assignment. |
Hypertext updated April 3, 2001 by tmc