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Bridging the Gap: Aligning GMP Requirements for Generic Manufacturing across the US, EU and Japan

Jayant Kumar1, Ajmera Ramkishan2, Madhugiri Prakash Venkatesh3,4★★ Corresponding author

  1. 1Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, S.S. Nagar, Mysuru, Karnataka, INDIA.
  2. 2Deputy Drugs Controller, Central Drugs Standard Control Organisation, Hyderabad, INDIA.
  3. 3Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.
  4. 4Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, MALAYSIA.

CORRESPONDENCE

Madhugiri Prakash Venkatesh

Department of Pharmaceutics, Pharmaceutical Regulatory Affairs Group, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Karnataka, INDIA.

venkateshmpv@jssuni.edu.in

Received: 17-04-2023; Revised: 18-05-2023; Accepted: 01-06-2023.

Volume 13, Issue 3 · pp. 432–439 · PUBLISHED · DOI: 10.5530/ijpi.13.3.054

View on IJPI original site ↗

ABSTRACT

Medications that are no longer covered by a patent and that are made by companies other than the original inventor are known as generics. In recent years, the use of generic medications has grown, principally as a cost-cutting tool in the delivery of healthcare. The typical price difference between generic and brand-name medications is 20 to 90%. The principal objective of laws governing pharmaceuticals in the US, Europe, and Japan is to protect public health. Good Manufacturing Practice (GMP) requirements in the United States, European Union, and Japan are designed to ensure that products are consistently produced and controlled according to quality standards. In the US, GMP regulations are enforced by the Food and Drug Administration (FDA). The EU has GMP guidelines that are enforced by national authorities, and Japan has its own GMP regulations that are enforced by the Ministry of Health, Labor, and Welfare. These regulations cover a wide range of areas including facilities, equipment, production processes and record keeping, which are put in place to ensure product quality and safety. Adhering to GMP requirements is essential for ensuring that products are manufactured to the highest standards and meet the expectations of consumers and regulatory authorities. Overall, the GMP requirements in these regions play a vital role in maintaining the safety and quality of products and are crucial for the pharmaceutical and food industries.

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    Kumar, J., Ramkishan, A., & Venkatesh, M. P. (). Bridging the Gap: Aligning GMP Requirements for Generic Manufacturing across the US, EU and Japan. International Journal of Pharmaceutical Investigation, 13(3), 432–439. https://doi.org/10.5530/ijpi.13.3.054