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Good Manufacturing Practices:

European Commission's Directorate for public health and risk assessment
This is the website of the European Commission's Directorate for public health and risk assessment. It provides information on policies and decisions taken at European, national and international level to protect Europeans' health by enabling them to make healthy choices and live healthier lives.
Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist: Updated April 24, 2008
Rigorous adherence to good manufacturing practice minimizes the risk of adulteration or misbranding of cosmetics. The following cosmetic establishment instructions, excerpted from FDA's Inspection Operations Manual, may serve as guidelines for effective self-inspection. A good inspection score means that an establishment follows good manufacturing practice.
A WHO guide to good manufacturing practice (GMP) requirements - Geneva 1997 Standard Operating Procedure and master formulae. An excellent document from The World Heath Organization: "WHO defines Good Manufacturing Practices (GMP) as “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization” (ref 27).

The FDA's "Pharmaceutical CGMPS for the 21st Century - A Risk Based Approach"
This is the final report, dated September 2004, is the culmination of FDA’s efforts that began in August 2002, to modernize the regulation of pharmaceutical manufacturing and product quality. The basis for this new direction is risk-based decision making throughout the manufacturing process.

21 CFR Parts 210, and 211. "Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; Current Good Manufacturing Practice For Finished Pharmaceuticals" Critical part of the CFR addressing requirements for manufacturing practice and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety and quality.

Current Good Manufacturing Practices In Manufacturing, Packaging, or holding Human Food Straight from the U.S. Food and Drug Administration, this is an Adobe Acrobat version of the federal regulations for manufacturing, packaging and holding of human food.

Version 2 of the Good Manufacturing Practices (GMP) Guidelines 2002 Edition
Written by the Health Products and Food Branch Inspectorate of the Canadian government, this document provides excellent guidelines for manufacturing. "This document replaces Version 1 of the GMP Guidelines 2002 Edition issued on December 1st, 2002, and the modification related to personnel published on May 23, 2002. This version also reflects changes made to Regulations as a result of the publication of Schedule 1247 on October 23, 2002."

World Health Organization: Annex 4 - Good Manufacturing Practices for Pharmaceutical Products: Main Principles
"...outlines the general concepts of quality assurance as well as the principal components or subsystems of GMP, which are joint responsibilities of top management and of production and quality control management."

Good Laboratory Practices:

Good Laboratory Practices Questions and Answers : Updated July 2007 " and Good Laboratory Practice for Non-Clinical Lab Studies (21 CFR part 58)
Largely based on the GMP, with a focus on the pre- or non-clinical stage of the drug development process, that is, one that involves non-human research.

White Paper on Master Control Software (21 CFR part 58)
Master Control is a popular piece of software to help ensure compliance to several CFRs; Part 58 being one of them.

Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR part 58)
Straight from the U.S. Food and Drug Administration, this is an Adobe Acrobat version of the federal regulations for laboratory practices.

Good Clinical Practices:

Protection Of Human Subjects (21 CFR part 50) This is one of a number of sections of the CFR that collectively make up the GCPs or Good Clinical Practices. Specifically, this section addresses requirements and precautions to be taken when conducting drug studies on human subjects.

Financial Disclosure By Clinical Investigators (21 CFR part 54) Also a section that makes up the GCPs, this part of the CFR addresses requirements for clinical trial investigators (or physicians), to disclose their financial compensation and arrangements with the trial sponsors to ensure that financial compensation for participating in the clinical trial does not unfairly affect the results.

Institutional Review Boards (IRBs) (21 CFR part 56) Another slice of the GCP pie, this section sets forth the responsibilities of the IRB or Institutional Review Boards in clinical trials. These IRBs are in large part responsible for the safety of human subjects in clinical trials.
\_ IRBMED Home Page (University of Michigan Medical School)

Investigational New Drug Application (21 CFR part 312) A critical part of the GCPs, this section lays out the requirements for packaging, labeling and distribution of clinical trial materials (experimental drugs) across state lines, for use in human studies.

Applications For FDA Approval To Market A New Drug (21 CFR part 314) The final section making up the GCPs represents the last stage of human studies, that is, once human studies have been completed and data evaluated, the sponsor (drug company), must formally apply to the FDA to secure permission to market its new drug. This section details the requirements for this new drug application (NDA) process.

E6 Good Clinical Practice: Consolidated Guidance This is a widely accepted, well respected and FDA-espoused guidance document developed by the International Conference on Harmonization that is intended to supplement/augment FDA’s own regulations and guidance around clinical trials. Its objective “…is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate a mutual acceptance of clinical data by the regulatory authorities of these jurisdictions.”

Clinical Safety Data Management: Definitions and Standards For Expedited Reporting (E2A)

Electronic Record, Electronic Signature [Part 11]:

FDA's validation guidance has been finalized - January 2011!

Code of Federal Regulations 21 CFR Part 11 @ fda.gov

21 CFR Part 11 has been Amended: A final rule regarding required records under the Public Health Security Act and Bioterrorism Preparedness and Response Act of 2002. It amends the scope to 21 CFR Parts 1 and 11.

Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. The official FDA guidance document released in September 2003.

Discovery Automation: The Benefits of 21 CFR Part 11 Compliance — Even if the FDA Never Asks for Your Records, written by Patrick Coffey, Ph.D. Excellent document on writing solid compliant software applications, a must read!

Executive Summary on New FDA Part 11 Guidance—The title says it all... this document is an executive summary of the April 2003 FDA Guidance on 21 CFR Part 11.

Meeting the FDA’s Requirements for 21 CFR Part 11 —For reference purposes only, this white paper provides one company’s perspective of meeting Part 11’s security requirements.

RSA^tm Security’s solutions as they relate to 21 CFR Part 11— This, like the previous link, provides an overview and interpretation of Part 11 from a perspective of how best to meet the security requirements of 21 CFR Part 11. It is by no means endorsed by this site.

Information Technology / Data Center (Validation and Qualification):

Qualification of Computer Networks and Infrastructure—In this paper, the authors "discuss some terms and definitions, the scope of the regulations and some recent regulatory actions and finally outline some approaches to aid qualification of computer networks and the associated infrastructure."

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices Published in 1997 by CDRH, this guidance document demonstrated some staying power and continues to be an effective reference not only for medical devices but other FDA-regulated areas as well. Since most software solutions implemented at major companies fit into the category know as COTS or Commercial Off-the-Shelf, this document is a good starting point.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff Another CDRH publication (2002), that provides some insight into what FDA is expecting to see in terms software validation deliverables for computer systems used to automate manual processes. As with the previous reference, a lot of good information can be gleaned from this document and applied to areas other than medical devices.

Risk Management Guide for Information Technology Systems This particular guidance developed by the National Institute of Standards and Technology (under the U.S. Department of Commerce) reflects the direction that the FDA seems to be headed in at the moment, that is, Risk Management. Essentially, this guidance documents introduces the reader to the risk-based approach for developing computer systems. Typically, employing the risk-based approach in development of anything yields a more streamlined, efficient product or process.

Editorial on "How to Survive an FDA Computer Validation Audit"

Medical Devices:

Quality System Regulation (21 CFR part 820) Simply put, this is the “GMP for Medical Devices”. FDA regulation that is quite similar to the cGMP (Parts 210 and 211), with an added bonus… a section on process validation.

Exemptions From Federal Preemption Of State And Local Medical Device Requirements (21 CFR part 808) A useful read for anyone working in the medical device arena, this regulation prohibits state or local governments’ inability from imposing additional/more stringent requirements on those entities producing medical devices that are intended for human use.

Medical Device Reporting (21 CFR part 803) This part of the CFR contains requirements for reporting serious injury or death caused by medical devices.

Medical Devices; Reports Of Corrections And Removals (21 CFR part 806) Another part of the CFR focused on patient safety as it pertains to medical devices. It lays out the reporting requirements for device manufacturers as well as requirements for the repair or removal of a device from a patient.

Pre-market Approval of Medical Devices (21 CFR part 814) This regulation is the rough equivalent of a New Drug Application (NDA) (in the pharmaceutical arena) and lays out the requirements that must be met before a medical device can be granted approval by the FDA as a marketable product.

New Drugs (21 CFR part 310) Written by CDRH, this regulation specifically applies to the packaging, labeling and handling of radiological drugs.

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices .

Other Parts of the CFR:

New Animal Drugs 21 (CFR part 510) Essentially, this regulation sets forth the requirements for record keeping, labeling and reporting on animal medicines, feeds and other animal products.

New Animal Drug Applications (21 CFR part 514) As the name indicates, this part of the CFR pertains to requirements for completing and submitting an application to market a new animal medicine.

New Animal Drugs For Investigational Use (21 CFR part 511) This regulation lays out the requirements for handling, distribution and labeling of animal medicines to be used for research purposes.

Sample FDA Warning Letter:

A Sample FDA Warning Letter FDA Warning letters are public documents and are available via searchable database at http://www.fda.gov/foi/warning.htm

This information is for educational purposes, however some documents may be marketing pieces or white papers from companies for a commercial product. We do not endorse or condone the use of any products mentioned in documents, nor do credit taken for writing any of these documents - this collection was created for your convenience.