Monitoring Regulatory Compliance within the Pharmaceutical Industry

References

1. JalundhwalaF. LondheV. A systematic review on implementing operational excellence as a strategy to ensure regulatory compliance: A roadmap for Indian pharmaceutical industry.Int. J. Lean Six Sigma202314473075810.1108/IJLSS‑04‑2022‑0078
   [Google Scholar]
2. LallasEN. SantouridisI. MountzourisG. GerogiannisVC. KarageorgosA. An SQWRL-based method for assessing regulatory compliance in the pharmaceutical industry.Appl. Sci. (Basel)202212211092310.3390/app122110923
   [Google Scholar]
3. AltamuroJLM. GrayJ. ZhangH.H. Corporate culture and compliance: A study of the pharmaceutical industry.Hoboken: New JerseyWiley2017428458
   [Google Scholar]
4. JochemR. LandgrafK. Quality management benchmarking: FDA compliance in pharmaceutical industry.Int. J. Health Care Qual. Assur.201023869069810.1108/0952686101108181321125964
   [Google Scholar]
5. LealF. ChisAE. CatonS, et al. Smart pharmaceutical manufacturing: Ensuring end-to-end traceability and data integrity in medicine production.Big Data Res20212410017210.1016/j.bdr.2020.100172
   [Google Scholar]
6. AppelK. Pharmaceutical distribution: Monitoring for compliance and risk.MHD Supply Chain Sol20114127074
   [Google Scholar]
7. NunavathRS. SinghM.T. JainA. ChakmaM. ArivuselvamR. AzeezeMSTA. Quality by design in pharmaceuticals: A review of its impact on regulatory compliance and product quality.Drug Res. (Stuttg.)2024741182338134919
   [Google Scholar]
8. AgarwalV. GuptaO. PriyadarshiniK. AgrawalS. A Failure of regulatory diligence and communication: A case study of Ranbaxy Laboratories Ltd.IJBMC20183417
   [Google Scholar]
9. MistryJ. Performance measurement in the pharmaceutical industry: Dr. Reddy’s Laboratories, Ltd.IEEE Eng. Manage. Rev.2018461526410.1109/EMR.2018.2809904
   [Google Scholar]
10. TremblayJ-F. Indian drug firms struggle with quality issues.Chem. Eng. News201694162325
    [Google Scholar]
11. ArnerDW. AuerR. FrostJ. Stablecoins: Risks, potential and regulation.SSRN202010.2139/ssrn.3979495
    [Google Scholar]
12. ArdenNS. FisherAC. TynerK. YuLX. LeeSL. KopchaM. Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future.Int. J. Pharm.202160212055410.1016/j.ijpharm.2021.12055433794326
    [Google Scholar]
13. BranchetP. Arpin-PontL. PiramA. BoisseryP. Wong-Wah-ChungP. DoumenqP. Pharmaceuticals in the marine environment: What are the present challenges in their monitoring?Sci. Total Environ.202176614264410.1016/j.scitotenv.2020.14264433077207
    [Google Scholar]
14. ThorleyM. FuldaA. The importance of leverage in GlaxoSmithKline’s China engagement: A revelatory case study.J. Curr. Chin. Aff.202049223325410.1177/1868102620931862
    [Google Scholar]
15. GudiN. KamathP. ChakrabortyT, et al. Regulatory frameworks for clinical trial data sharing: Scoping review.J. Med. Internet Res.2022245e3359110.2196/3359135507397
    [Google Scholar]
16. FebrianiH. WinotoBMP. MaharaniC. Corporate liability of pharmaceutical companies producing unsafe drugs (Lesson-Learnt from the USA).Jurnal Hukum Volkgeist20238199107
    [Google Scholar]