International Journal of Drug Regulatory Affairs

  • Year: 2020
  • Volume: 8
  • Issue: 4

Good manufacturing practice (GMP): History, structure and its significance

Dept. of Applied Chemistry, Amity University, Noida, Sector-126, Uttar Pradesh, India, 201301

*Corresponding author Tel.: +91-9953402923, E-mail address: abhimanyurampal5@gmail.com (Abhimanyu Rampal)

Online published on 24 May, 2021.

Abstract

Good Manufacturing Practice (GMP) is set of guidelines enforced by USFDA under 21 CFR. Every Manufacturer of Food, Cosmetics, Pharmaceuticals products, Medical Devices & Dietary products should follow these guidelines in order to be sure that their product is safe and effective to be put in the market and for use by general population. The parameters of GMP for different Categories may vary but there is only one aim & that is to prevent any kind of harm that can occur to the final user of the product.

Keywords

GMP, USFDA, EUROPE, CANADA, TGA, ANVISA