Compliance programs auditing

FDA compliance policy guide section 130.000, FDA access to results of quality assurance program audits and inspections (CPG 7151.02), available http //www.fda.gov/ora/ compliance ref/cpg/cpggenl/cpgl30-300.html, accessed Dec. 5, 2006. 

The OECD Guidelines for National GLP Inspections and Study Audits document serves as a companion document to the Principles and is intended to provide national authorities additional guidance in preparing and implementing their national GLP compliance programs. 

FDA (1986), FDA Access to Results of Quality Assurance Program Audits and Inspections, Compliance Policy Guide 7151.02, U.S. Food and Drug Administration, Rockville, MD. 

Compliance/Regulatory Training Program Audit Requirements Other Relevant Subjects... 

The conduct of audits is not a mandatory requirement in GCP. ICH GCP (1995) mentions in section 5.19 If and when sponsors perform audits, as part of implementing quality assurance - this is not interpreted as an obligation to establish an audit program. Similarly, FDA does not mandate the conduct of audits (FDA Compliance Program Guidance Manual, 2006). 

The company acquiring the facility should recruit process safety experts to evaluate the quality of the PSM program. This evaluation goes beyond a simple compliance-style audit— it aims to determine if the management system is working properly. 

Safety professionals should provide legal counsel with written compliance programs, written safety policies, documentation of fair and consistent disciplinary action for violations, training and education documentation, as well as safety inspections, safety audits, and related documentation. Please be aware that some of the circuit courts require the defense of unpreventable employee misconduct to be plead as an affirmative defense prior to filing with the OSHRC. 

CAUTION The following excerpts are fiom the OSHA Notice CPL 2, distributed on August 1, 1996, by the Directorate of Compliance Programs. This Program Evaluation Profile (PEP) notice was cancelled on November 15, 1996. This document is provided as an EXAMPLE of an auditing tool to assist in the evaluation of a Safety and Health Program. 

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