Pharmaceutical Industry Surveillance

Government oversight of the pharmaceutical industry is usually classified into preapproval and post-approval categories. Most of the therapeutically significant compounds marketed today are the subject of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Preapproval activities, based on these detailed applications, are used to assure the drug is safe and effective before marketing. The Center for Drug Evaluation and Research (CDER) is the FDA organization responsible for drug evaluation and approval. Before approval, the FDA may inspect and audit the development facilities, planned production facilities, clinical trials, institutional review boards, and laboratory facilities in which the drug was tested in animals.

After the drug is approved and marketed, the FDA uses different mechanisms for assuring that firms adhere to the terms and conditions of approval described in the application and that the drug is manufactured in a consistent and controlled manner. This is done by periodic unannounced inspections of drug production and control facilities by FDA’s field investigators and analysts. These professionals are organized under FDA’s Office of Regulatory Affairs (ORA), which has twenty-one district offices and many more resident posts throughout the country.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides legal authority for inspections and access to factories, vehicles, equipment, records, processes, and controls necessary to determine that drugs are being produced in conformance with regulations that have the force of law. These regulations, Current Good Manufacturing Practice for Finished Pharmaceuticals, are contained in Part 211 of Title 21 of the U.S. Code of Federal Regulations. These regulations contain requirements for: Organization and Personnel; Buildings and Facilities; Equipment; Components, Containers, and Closures; Production and Process Control; Packaging and Labeling; Distribution; Laboratory; and Reports and Records.

The regulations are general enough to be applied to a wide variety of dosage form drugs from topical ointments and creams to sterile injectables and ophthalmics. Yet, they are specific enough to require: testing of every batch for conformance with specifications before release, manufacture according to a specific master formula and process, validation of all manufacturing and control processes, investigation of complaints and failures, annual evaluation of products, testing program to assure stability of product throughout its labeled life, and testing of components and ingredients.

FDA investigators often use additional information from a variety of market surveillance systems to assist them in identifying a manufacturing or control problem. Consumer complaints, MedWatch submissions, NDA Field Alerts, Drug Quality Reporting System, and Adverse Drug Experience Reports are some of the systems used to identify drug problems by FDA’s epidemiological units. FDA investigators also have access to a large variety of state-of-the-art analytical facilities throughout the country. These laboratories confirm suspected chemical, physical, and microbiological problems with pharmaceuticals; verify and develop analytical methods; and conduct research.

This system of regulation has grown with the pharmaceutical industry through many crises and challenges. The FDA welcomes dialogue with other regulatory bodies, industry organizations, Congress, and the public to improve the efficiency of its regulatory and administrative processes.

For more information, contact the Office of Compliance, Division of Manufacturing and Product Quality (DMPQ) at (301)594-0093, or contact FDA's Office of the Commissioner, Office of Regulatory Affairs at (301)443-6230. You can also visit DMPQ's CGMP Web Page or see the Office of Compliance FY 1996 Annual Report.