Compliance programs

Occupational Safety and Health Administration Directorate of Compliance Programs 200 Constitution Avenue, N.W Washington, D.C. 20210... 

Occupational Safety Flealth Compliance Program Powers-Taylor Bldg., 13 S. 13th St. Richmond, VA 23219 USA... 

All UK facilities conducting regulatory studies must be members of the UK Good Laboratory Practice compliance program and all regulatory studies must be conducted... 

All phases of a multi-site regulatory study should be carried out in facilities that are members of the UK or a relevant national GLP compliance program. Pre-study test site inspections may be conducted if considered necessary. If an organization is considering using a particular test site, a copy of the test facility s current GLP certificate should be obtained and included in the QA multi-site file. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

In addition to the regulations under 21 CFR, the FDA publishes Guidance for Industry and documents called Points to Consider (PTCs) as guidelines and recommendations to industry to adopt as part of the compliance program. 

Food and Drug Administration. The Compliance Program Guidance Manual for FDA Staff Drug Manufacturing Inspections Program 7356.002, FDA, RockviUe, MD, 2007. 

Food and Drug Administration (FDA). Compliance Program GuidanceManual(7348-811)Clinicallnvest-igators. RockviUe, MD Division of Compliance Policy, 1999. 

To develop and utilize an information base on ciguatera for the seafood industry, health personnel, the public, and researchers. To identify the factors contributing to the entry of ciguateric fish into the marketplace and to develop procedures (e.g., surveillance/compliance programs) to minimize the consumption of toxic fish. 

U.S.E.P.A. Office of Inspector General, Evaluation Report 2004-P-00021. EPA Needs to Impmve Tracking of National Petroleum Refinery Compliance Program Progress and Impacts. June 22, 2004. 

Food and Drug Administration, Office of Planning and Evaluation. OPE Study 42 Results of the Nonclinical Laboratory Good Laboratory Practices Pilot Compliance Program. Sept. 1977. 

FDA compliance program guidance manual for FDA staff Drug manufacturing inspections program (7356.002), 2/1/2002, available http //www.fda.gov/cder/dmpq/compliance guide.htm, accessed Dec. 5,2006. 

The objective of the compliance program is to ensure that establishments involved in the manufacturing, testing, or... 

Blozan, C.F., "Results of the nonclinical toxicology laboratory Good Laboratory Practices pilot compliance program,"... 

United States Pood and Drug Administration (2006) Drug quality assurance, in FDA Compliance Program Guidance Manual, Ch. 56, United States Food and Drug Administration, pp. 1-28. 

FDA compliance program guidance manual. National drug residue milk monitoring program. Food and drag administration. Rockville, MD, section 7303.039,1997. 

The term process validation is not defined in the Food, Drug, and Cosmetic Act (FD C) Act or in FDA s CGMP regulations. Many definitions have been offered that in general express the same idea—that a process will do what it purports to do, or that the process works and the proof is documented. A June 1978 FDA compliance program on drug process inspections [2] contained the following definition ... 

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. 

This aspect is particularly helpful to organizations that are starting a GLP compliance program. SOPs that address procedures such as preparing and amending protocols and final reports, help to ensure that standard practices are used in the organization. 

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