Understanding and Keeping Current With Compliance
Key Standards, Laws, Regulations, and Guidelines
Click here to learn about the different standards, laws, regulations and guidelines that impact GMP compliance and quality. This page also includes links to international governmental agencies which create and enforce manufacturing standards for the life sciences.
Key Compliance Support Documents
FDA's Regulatory Procedures Manual
The Regulatory Procedures Manual provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement activities. While the RPM is intended mainly to provide guidance to FDA inspectors, investigators, and compliance officers, the document is likely to be useful to industry as well.Key FDA Compliance Guidelines
This page provides links to FDA guidelines which are relevant to GMP compliance.Compliance Policy Guides
This links to FDA's Compliance Policy Guides (CPG) Manual, which provides a convenient and organized system for statements of FDA compliance policy, including those statements which contain regulatory action guidance information. The CPG Manual is the repository for all agency compliance policy that has been agreed to by the center(s) and the Associate Commissioner for Regulatory Affairs. Examples of sources from which CPGs are prepared include: a) statements or correspondence by headquarters offices or centers reflecting new policy or changes in compliance policy including Office of the Commissioner memoranda, center memoranda and other informational issuances, agency correspondence with trade groups and regulated industries, and advisory opinions; b) precedent court decisions; c) multicenter agreements regarding jurisdiction over FDA regulated products; d) preambles to proposed or final regulations or other Federal Register documents; and f) individual regulatory actions.Compliance Program Guidance Manual
FDA compliance programs provide guidance and instructions to FDA staff for obtaining information to help fulfill agency plans in the specified program area. Guidance is divided into the following subject areas: Biologics, Bioresearch Monitoring (BIMO), Devices/Radiological Health, Drugs, Food/ Cosmetics, and Veterinary Medicine.Quality Systems Inspections Technique (QSIT)
The Guide to Inspections of Quality Systems provides instructions for conducting medical device quality system/GMP inspections. It is to be used in conjunction with the compliance program entitled Inspections of Medical Device Manufacturers (7382.845). The guide was prepared by the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA), and the Center for Devices and Radiological Health (CDRH). It provides guidance for inspecting medical device manufacturers against the Quality System Regulation (21 CFR Part 820) and related regulations.Medical Device Quality Systems Manual: A Small Entity Compliance Guide
Information on Electronic Records and Electronic Signatures
The GMP Institute has compiled a page full of documents and products to help companies comply with 21 CFR Part 11. Resources include a history of rulemaking, guidance documents, a white paper, other compliance documents and available products.
If you need to know more about the FDA, what it does, and how it works, this is the place for you. This page provides links to a variety of different resources on FDA, helping you to get to know the agency better.
Inspection Process and Strategies
Do Your Own Inspection: A Guide To Self-Inspection For The Smaller Food Processor and Warehouser
By inspecting your own establishment, you can see if your operation could face regulatory problems. This booklet published by FDA will aid smaller food processors and warehousers in performing a check of your own operations so that the FDA inspection will not necessarily surprise you with its findings. While not a substitute for the FDA establishment inspection, conducting your own "self inspection" can help you to detect and solve compliance problems you might have before they get out of hand.Hosting FDA Inspections
This article, written by a former GMP Institute senior consultant with many years of field experience, tells you how to prepare for an FDA inspection so that it will go as smoothly as possible. It is a valuable tool for anyone who is involved in dealing with an inspection, from the front desk person to senior management.Investigations Operations Manual
The Investigations Operations Manual (IOM) is the primary source of guidance regarding Agency policy and procedures for field investigators and inspectors. This extends to all individuals who perform field investigational activities in support of the Agency's public mission. Accordingly, it directs the conduct of all fundamental field investigational activities. As such, it can be very helpful for life science professionals, as it is a good tool to learn what to expect from FDA.Inspectional References
This page presents information provided to FDA investigators and inspectors to assist them in their daily activities. Some references included are: Field Management Directives, Guides to Inspections, Investigations Operations Manual, Inspection Technical References, Medical Device GMP Reference Information, and QS Regulation/Design Controls.Quality Systems Inspections Technique (QSIT)
This document was developed by FDA to create an inspection program covering the quality systems regulation, which results in more focused and efficient inspections. It helps FDA investigators focus in on key manufacturing and quality areas at the manufacturer during inspections, in order to determine their state of compliance with the Quality Systems Regulation.Compliance Program Guidance Manual: Inspection of Medical Devices; Final Guidance For FDA and Industry
This guidance document represents FDA's current thinking on the enforcement of the Quality System/Good Manufacturing Practices (QS/GMP), Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals (CAR), and the Registration and Listing Regulations.Compliance Program Guidance Manual For FDA Staff: Drug Manufacturing Inspections
This compliance program is designed to provide guidance for evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested and held. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control.
Non-Compliance
Recalls: FDA, Industry Cooperate to Protect Consumers
This article from FDA Consumer explains what recalls are, when they are used, how they are carried out, and how FDA works with industry in the event of a recall to protect consumers.FDA Recall Policies
This article published by FDA's Center For Food Safety and Applied Nutrition, explains FDA's role in a recall, and the policies it uses.Information on Recalls of FDA Regulated Products
This page publishes information that FDA provides on recalls, including guidance for industry..Inside FDA: Barring People from the Drug Industry
This article from FDA Consumer explains the process of debarring people from the drug industry. This is a practice whereby FDA forbids people (or firms) convicted of certain crimes--basically, crimes related to FDA's regulation of drugs--from participating in the drug industry.Debarment List
This page lists people who have been debarred, or legally excluded from working in the drug industry due to crimes they have committed.Warning Letters and Untitled Letters to Pharmaceutical Companies (2005)
This page links to warning letters and untitled letters issued to pharmaceutical companies in the year 2005. Some letters have been redacted or edited to remove confidential information.
GMP and Performance Management
The 10 Principles of GMP break the concept of GMP compliance and performance down into 10 action items. Using these items will help you to stay focused on what is important.
Framework for Integrating Regulations and Standards
The GMP Institute's Framework for Integrating Regulations and Standards is detailed in this section. It provides a list of controls broken down into seven areas, which should be evaluated in order to assure that you are operating in a state of control. Use this framework as to help as you continuously improve your systems, enhancing your levels of compliance and performance.
This article explains how GMP and quality management can work together to help you meet your corporate goals and to increase the profitability of your company.
