BOX 46 Current Good Manufacturing Practice cGMP

The FDA through the establishment of the Good Manufacturing Practice (GMP) regulation ensures that drugs produced by pharmaceutical companies consistently meet quality specification. Since it was first introduced in 1963 as a part of the Kefauver-Harris Drug Amendment of 1962, it has been updated periodically. The latest version is called current GMP (cGMP) regulation. Information is posted on the FDA's Web site (http://www.fda.gov/cder/dmpq/ cgmpregs.htm). The cGMP regulations encompass the minimum standard expected of a manufacturing site with regard to facility, equipment, personnel, control of raw materials, production, process, packaging, labeling, holding, and distribution. In addition, the cGMP regulations also include the recording and reporting of all the manufacturing processes as well as the disposal of unused products.

The FDA inspects domestic manufacturing plants as well as foreign drug manufacturing facilities that export drugs to the United States to ensure full compliance, and provide assurance that pharmaceutical products consistently meet uniform quality standards. Failure to meet qualify standards may have impacts on a drug's efficacy and safety. The FDA can shut down a facility that fails to comply with cGMP regulations. The following lists the range of issues covered under the cGMP standard.

A. General Provisions

2. Definitions.

B. Organization and Personnel

1. Responsibilities of quality control unit.

2. Personnel qualifications.

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