Login Register Cart 0
Applied Drug Research, Clinical Trials and Regulatory Affairs

Applied Drug Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

Back
Journal Home About Journal Editorial Board Current Issue Volumes/Issues
Subscribe
Editorial

Monitoring Regulatory Compliance within the Pharmaceutical Industry

Author(s): Md Moidul Islam and Sarjana Raikwar*

Volume 10, 2024

Published on: 03 June, 2024

Article ID: e030624230611 Pages: 4

DOI: 10.2174/0126673371317148240529112603

Become a Editorial Board Member
Become a Reviewer
Become a Editor
Become a Section Editor
[1]
Jalundhwala F, Londhe V. A systematic review on implementing operational excellence as a strategy to ensure regulatory compliance: A roadmap for Indian pharmaceutical industry. Int J Lean Six Sigma 2023; 14(4): 730-58.
[http://dx.doi.org/10.1108/IJLSS-04-2022-0078]
[2]
Lallas EN, Santouridis I, Mountzouris G, Gerogiannis VC, Karageorgos A. An SQWRL-based method for assessing regulatory compliance in the pharmaceutical industry. Appl Sci (Basel) 2022; 12(21): 10923.
[http://dx.doi.org/10.3390/app122110923]
[3]
Altamuro JLM, Gray J, Zhang HH. Corporate culture and compliance: A study of the pharmaceutical industry. Hoboken: New JerseyWiley 2017; pp. 428-58.
[4]
Jochem R, Landgraf K. Quality management benchmarking: FDA compliance in pharmaceutical industry. Int J Health Care Qual Assur 2010; 23(8): 690-8.
[http://dx.doi.org/10.1108/09526861011081813] [PMID: 21125964]
[5]
Leal F, Chis AE, Caton S, et al. Smart pharmaceutical manufacturing: Ensuring end-to-end traceability and data integrity in medicine production. Big Data Res 2021; 24: 100172.
[http://dx.doi.org/10.1016/j.bdr.2020.100172]
[6]
Appel K. Pharmaceutical distribution: Monitoring for compliance and risk. MHD Supply Chain Sol 2011; 41(2): 70-4.
[7]
Nunavath RS, Singh MT, Jain A, Chakma M, Arivuselvam R, Azeeze MSTA. Quality by design in pharmaceuticals: A review of its impact on regulatory compliance and product quality. Drug Res (Stuttg) 2024; 74(1): 18-23.
[PMID: 38134919]
[8]
Agarwal V, Gupta O, Priyadarshini K, Agrawal S. A Failure of regulatory diligence and communication: A case study of Ranbaxy Laboratories Ltd. IJBMC 2018; 3(4): 17.
[9]
Mistry J. Performance measurement in the pharmaceutical industry: Dr. Reddy’s Laboratories, Ltd. IEEE Eng Manage Rev 2018; 46(1): 52-64.
[http://dx.doi.org/10.1109/EMR.2018.2809904]
[10]
Tremblay J-F. Indian drug firms struggle with quality issues. Chem Eng News 2016; 94(16): 23-5.
[11]
Arner DW, Auer R, Frost J. Stablecoins: Risks, potential and regulation. SSRN 2020.
[http://dx.doi.org/10.2139/ssrn.3979495]
[12]
Arden NS, Fisher AC, Tyner K, Yu LX, Lee SL, Kopcha M. Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future. Int J Pharm 2021; 602: 120554.
[http://dx.doi.org/10.1016/j.ijpharm.2021.120554] [PMID: 33794326]
[13]
Branchet P, Arpin-Pont L, Piram A, Boissery P, Wong-Wah-Chung P, Doumenq P. Pharmaceuticals in the marine environment: What are the present challenges in their monitoring? Sci Total Environ 2021; 766: 142644.
[http://dx.doi.org/10.1016/j.scitotenv.2020.142644] [PMID: 33077207]
[14]
Thorley M, Fulda A. The importance of leverage in GlaxoSmithKline’s China engagement: A revelatory case study. J Curr Chin Aff 2020; 49(2): 233-54.
[http://dx.doi.org/10.1177/1868102620931862]
[15]
Gudi N, Kamath P, Chakraborty T, et al. Regulatory frameworks for clinical trial data sharing: Scoping review. J Med Internet Res 2022; 24(5): e33591.
[http://dx.doi.org/10.2196/33591] [PMID: 35507397]
[16]
Febriani H, Winoto BMP, Maharani C. Corporate liability of pharmaceutical companies producing unsafe drugs (Lesson-Learnt from the USA). Jurnal Hukum Volkgeist 2023; 8(1): 99-107.

Rights & Permissions Print Cite
Article Metrics
Pdf icon 23
Html icon 3
E-pub icon 1
PRC icon 4
Find your institution