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Compliance Policy Guide
Sec. 130.300
*FDA Access to Results of Quality Assurance Program Audits and Inspections*
(CPG 7151.02)
BACKGROUND:
*Within all FDA regulated industries, some firms establish quality assurance units (QAU) to perform functions independently from the manufacturing or quality control organization. The QAU may periodically audit and critically review processes and procedures (for example, data collection, manufacturing practices, and quality control processes) to determine whether established protocols and procedures have been followed.
In the preambles to the final regulations on Good Manufacturing Practice for Medical Devices (43 FR 31508; July 21, 1978) (21 CFR 820) and on Good Laboratory Practice for Nonclinical Laboratory Studies (43 FR 59986; December 22, 1978) (21 CFR 58), FDA announced its policy not to review or copy a firm's records and reports that result from audits of a quality assurance program when such audits are conducted according to a firm's written quality assurance program at any regulated entity. The intent of the policy is to encourage firms to conduct quality assurance program audits and inspections that are candid and meaningful.*
POLICY:
*During routine inspections and investigations conducted at any regulated entity that has a written quality assurance program, FDA will not review or copy reports and records that result from audits and inspections of the written quality assurance program, including audits conducted under 21 CFR 820.20(b) and written status reports required by 21 CFR 58.35(b)(4).*
FDA may seek written certification that such audits and inspections have been implemented, performed, and documented and that any required corrective action has been taken. District personnel should consult with the appropriate headquarters office prior to seeking written certification.
*FDA will continue to review and copy records and reports of such audits and inspections:
1. In "directed" or "for-cause" inspection and investigations of a sponsor or monitor of a clinical investigation;
2. In litigation (for example, and not limited to: grand jury subpoenas, discovery, or other agency or Department of Justice law enforcement activity (including administrative regulatory actions));
3. During inspections made by inspection warrant where access to records is authorized by statute; and
4. When executing any judicial search warrant.
FDA will continue to have access to, review, and copy records and reports required by regulation, relating to quality control investigations of product failures and manufacturing errors.*
*Material between asterisks is new or revised.*
Issued: 03/01/83
Revised: 03/16/89
Revised: 06/03/89
Revised: 01/03/96