内审记录和报告可以豁免检查的依据是什么？
内审记录和报告可以豁免检查的依据是什么？
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来源：gmp干货
内审记录和报告在接受GMP检查/审计时，可以豁免被检查，这个理念基本都深入人心。但是这种实践是否有法规/指南的支持呢？
答案是有法规依据。FDA监管事务办公室发布过合规政策指南，其中就提到，FDA正常情况下不会审查内审/自检记录和报告，但是可能会寻求内审/自检已完成的书面证明，并采取了任何必要的纠正措施。另外，在涉及到司法程序时，FDA是有权查看 内审/自 检 记录和报告的。
以下是合规政策指南的全部内容。
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
CPG第130.300章节FDA获取质量保证程序审计和检查结果
JUNE 2007
2007年6月
发布机构：监管事务办公室
文件发布日期：2007年6月2日
This document supersedes Compliance Policy Guide (CPG) "Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)" that was issued on January 3, 1996.
美国卫生与公众服务部
美国食品药品监督管理局
监管事务办公室
执法办公室
合规政策司
Preface
前言
Public Comment
公众意见
:
Written comments regarding this document may be submitted to the Division of Dockets Management (HFA-305), Food and Drug admin126459646istration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments t
o http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm.
For questions regarding the use or interpretation of this guidance, contact Jeffrey Governale at 240-632-6851.
Additional Copies
额外的副本
:
Submit written requests for a single copy of the guidance to the Division of Compliance Policy (HFC-230), Office of Regulatory Affairs, Food and Drug admin126459646istration, 5600 Fishers Lane, Rockville, MD 20857-001, or FAX your request to240-632-6861. A copy of the guidance may also be downloaded to a personal computer with access to the Internet. The Office of Regulatory Affairs’ site includes the guidance and may be accessed a
t http://www.fda.gov/ora/compliance_ref/revisions.htm.
COMPLIANCE POLICY GUIDE 合规政策指南
This guidance represents the Food and Drug admin126459646istration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidance means that something is suggested or recommended, but not required.
Compliance Policy Guide
合规政策指南
Sec.
章节
130.300
FDA获取质量保证项目审核和检查结果(CPG 7151.02)
BACKGROUND
背景
：
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 *the Quality System Regulation* - Good Manufacturing Practice for Medical Devices (*61 FR 52602; October 7, 1996*) (21 CFR *Part* 820) and on Good Laboratory Practice for Nonclinical Laboratory Studies (43 FR 59986; December 22, 1978) (21 CFR *Part* 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
政策
：
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 *820.22* and written status reports required by 21 CFR 58.35(b)(4).
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 admin126459646istrative 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.
* *号之间的内容是新的或修订的