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United States GMP Compliance Documents
- FDA's Regulatory Procedures Manual
Provides 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 GMP Compliance Guidelines
This page provides links to FDA guidelines which are relevant to GMP compliance.
- Compliance Policy Guides
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
Provides 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)
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
Covers the Quality System regulation and the basic Good Manufacturing Practices (GMP) requirements that all manufacturers and distributors must consider when they plan to manufacture medical devices, including medical device kits, trays or packs, for distribution in the United States. Model procedures and sample forms are also included in the manual to assist manufacturers.