Author(s):
K. Bhavya Sri, Saba Fatima, M. Sumakanth
Email(s):
bhavya.khagga@gmail.com
DOI:
10.52711/2231-5659.2026.00038 
Address:
K. Bhavya Sri1*, Saba Fatima1, M. Sumakanth2
1Department of Pharmaceutical Analysis, RBVRR Women’s College of Pharmacy, 3-4-343, Barkatpura, 500027, Hyderabad, India.
2Department of Pharmaceutical Chemistry, RBVRR Women’s College of Pharmacy, 3-4-343, Barkatpura, 500027, Hyderabad, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 3,
Year - 2026
ABSTRACT:
Code of Federal Regulations (CFR) is official publication having the codification of the general and the permanent rules and regulations distributed in Federal Register. Title 21 of the CFR deals with the governing Food and Drugs in the United States of America. The 21 CFR and its recommendations have a significant role in today's pharmaceutical industry. It has a total of 9 volumes in which 3 chapters and their subchapters and parts are distributed. Title 21 CFR includes some important parts like the Part 11 which covers the electronic records and the electronic signatures, part 50 concerned with the protection of the human subjects in which the Informed human consent and all its details are described, part 58 deals with the good laboratory practices for the non-clinical laboratory studies, cGMP (Current Good Manufacturing Practices) covered in parts 210, and 211 used in pharmaceutical industry. These parts, rules, and regulations covered are useful for producing and maintaining quality standard pharmaceutical products. Compliance to these parts increases the opportunity of a pharmaceutical company to get approval from the FDA for marketing their formulation.
Cite this article:
K. Bhavya Sri, Saba Fatima, M. Sumakanth. A Review on the Influence of Title 21 CFR Regulations in Pharmaceutical Manufacturing and Compliance. Asian Journal of Research in Pharmaceutical Sciences. 2026; 16(3):255-4. doi: 10.52711/2231-5659.2026.00038
Cite(Electronic):
K. Bhavya Sri, Saba Fatima, M. Sumakanth. A Review on the Influence of Title 21 CFR Regulations in Pharmaceutical Manufacturing and Compliance. Asian Journal of Research in Pharmaceutical Sciences. 2026; 16(3):255-4. doi: 10.52711/2231-5659.2026.00038 Available on: https://www.ajpsonline.com/AbstractView.aspx?PID=2026-16-3-7
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