Compliance policy

FDA. Draft Guidance for Industry on Part 11, Electronic Records Electronic Signatures—Scope and Application Availability of Draft Guidance and Withdrawal of Draft Part 11 Guidance Documents and a Compliance Policy Guide, Fed Regr 68 (37), 8775-6 (25 Eebruary 1997). 

FDA. 1992a. Lead in ceramic foodware revised compliance policy guide availability. Department of Health and Human Services, Food and Drug Administration, Washington, DC. Federal Register... 

The first and foremost element for GMP is the quality system. This can be divided into Quality Assurance (QA) and Quality Control (QC). QA is a total system approach. It sets out the compliance policies and procedures for all facets of drug manufacturing. QC is the practical extension of QA. The role of QC is concerned with inspection and testing of the manufacturing environment, raw materials, in-process intermediates, and finished products. 

The interest of the Food and Drug Administration (FDA) in compounding by and for veterinarians dates back to the early 1990s. The avowed purpose of the symposium in 1993 was to provide a forum for a eomprehensive, public debate in response to the Ameriean Veterinary Medieal Assoeiation (AVMA) position on eompormding prior to the issuanee of the FDA Compliance Policy Guide on veterinary eompotmd-... 

Food and Drug Administration (FDA). Guidance for Industry - Computerised Systems Used in Clinical Trials. RockviUe, MD Division of Compliance Policy, 1999. 

In several major countries GMP regulations are considered official law and noncompliance is prosecutable. Additional compliance policies, guides, and guidelines are not legally binding. However, the pharmaceutical industry follows them as a part of good management and business practice. 

Compliance Policy Guide 7132c.08. Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval. FDA. http //www.fda.gov/ora/compliance ref/cpg/ cpgdrg/cpg490-100. html. 

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. 

Food and Drug Administration, in Extra-Label Lise of New Animal Drugs in Food-Producing Animals, Compliance Policy Guide 7126.06, Food and Drug Administration, Rockville, M.D. (1986). 

Does the system provide adequate documentation of the application With this in mind and to achieve and maintain validated computer systems, pharmaceutical manufacturers need to include the following as part of their compliance policy ... 

Examples of the U.S. regulations applicable to computer system application in a GMP environment are shown in Table 1. The FDA also publishes compliance policy guides [7] related to pharmaceutical drag products and views the guidance provided on related products (e.g., medical devices [8]) to be current good manufacturing practice that should be considered for comparative GMP applications. 

Chapter 21 covers the most recent Compliance Policy Guide 7153.17 applicable to computer systems. The scope of this guide is Part 11. 

FDA, Compliance Policy Guide 7132a. 15, Source Code for Process Control Application Programs, April 1987. 

Standard operating procedures Compliance policy guides... 

Compliance References. This Web site from the Office of Regulatory Affairs provides links to compliance policy guides, regulatory procedures... 

Drug Application Regulatory Compliance. This Web page offers guidance documents, compliance policy programs and guidelines, and frequently asked questions about compliance activities. 

Because of instances of fraud, the FDA has instituted procedures for the debarment of individuals. An NDA needs to contain a certification that the applicant has not and will not use the services of any debarred individual in any capacity (14). Notices of the debarment of individuals are published in the Federal Register. The current debarment list is available from the FDA internet site or from the Division of Compliance Policy. Note that the certification includes the statement that the applicant will not use any debarred person in the future. Thus, it is recommended that the list be checked periodically, especially before letting any contracts. The FDA has been interpreting the phrase in any capacity to include jobs that are not involved with drug development, such as landscaper or accountant. 

Under the direction of the chief compliance officer and the corporate compliance committee, each organization should develop written compliance policies that pertain to the organization s practices that may be at risk for noncompliance. The policy should clearly delineate the organization s commitment to comply with all federal and state standards, with an emphasis on preventing fraud and abuse. The compliance plan should address, at a minimum, the False Claims Act, the Anti-kickback Statutes, physician self-referral laws, and laws regarding bribery and improper gifts. Once the plan is developed, it should be reviewed and approved by the organization s board of directors. 

First FDA Compliance Policy Guide (CPG) on computer systems — Computerized Prescription Record Keeping by Pharmacies... 

Compliance Policy Guide (1999), Enforcement Policy, 7153.17 21 CFR Part 11 Electronic Records, Electronic Signatures, Food and Drug Administration, Rockville, MD. 

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