U.S. Food and Drug Administration

Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with …

2025年1月21日 · The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals. Consumers …

CGMP regulations generally address matters including appropriate personal hygienic practices, design and construction of a food plant and maintenance of plant grounds, plant equipment, …

(a) The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or …

§ 110.5 Current good manufacturing practice. (a) The criteria and definitions in this part shall apply in determining whether a food is adulterated. (1) within the meaning of section 402 (a) …

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing information in different file formats, see...

2024年11月4日 · cGMP guidelines cover every aspect of production, from facility design to staff training, equipment calibration, quality control, and record-keeping. These practices help …

CGMP Regulations. GMP regulations are included in Title 21 Chapter 1 of the CFR, in three regulations dealing with different types of manufactured products: for drugs (21 CFR 211) for …

2024年4月17日 · Current Good Manufacturing Practice (cGMP guidelines) requirements are set up by the Food and Drug Administration (FDA) and serve as the benchmark for testing the …