Drugs

Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations

Introduction

FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  The CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.  The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.

The approval process for new drug and generic drug marketing applications includes a review of the manufacturer's compliance with the CGMP.  FDA inspectors determine whether the firm has the necessary facilities, equipment, and skills to manufacture the new drug for which it has applied for approval.   Decisions regarding compliance with CGMP regulations are based upon inspection of the facilities, sample analyses, and compliance history of the firm. This information is summarized in reports which represent several years of history of the firms.

FDA can issue a warning letter or initiate other regulatory actions against a company that fails to comply with Current Good Manufacturing Practice regulations.  Failure to comply can also lead to a decision by FDA not to approve an application to market a drug.

This web page provides links to resources to help drug manufacturers comply with the Current Good Manufacturing Practice regulations.

Federal Regulations

 Code of Federal Regulations (CFR).  The final regulations published in the Federal Register (daily published record of proposed rules, final rules, meeting notices, etc.) are collected in the CFR.  The CFR is divided into 50 titles which represent broad areas subject to Federal regulations.  The FDA's portion of the CFR interprets the Federal Food, Drug and Cosmetic Act and related statutes.  Section 21 of the CFR contains most regulations pertaining to food and drugs.  The regulations document the actions of drug sponsors that are required under Federal law. 

Guidance Documents

Guidance documents represent the Agency's current thinking on a particular subject. These documents are prepared for FDA review staff and drug sponsors to provide guidelines for the processing, content, and evaluation of applications, and for the design, production, manufacturing, and testing of regulated products.  They also provide consistency in the Agency's regulation, inspection and enforcement procedures.  Because guidances are not regulations or laws, they are not enforceable.  An alternative approach may be used if it satisfies the requirements of the applicable statute, regulations, or both.

CDER Manual of Policies and Procedures (MaPPs)

MaPPs are approved instructions for internal practices and procedures followed by CDER staff to help standardize the new drug review process and other activities.  MaPPs define external activities as well.  All MaPPs are available for the public to review to get a better understanding of office policies, definitions, staff responsibilities and procedures.

Compliance Policy Programs and Guidelines

Compliance Questions and Answers

Page Last Updated: 12/17/2014
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