Recent Technology and Software for GDP in the Pharmaceutical Industry

DOI:

https://doi.org/10.37285/ijpsn.2023.16.5.9

Authors

  • Mamta Kumari Department of Pharmacology, Maharana Pratap College of Pharmacy, Kanpur Uttar Pradesh India.
  • Anubhav Dubey Department of Pharmacology, Maharana Pratap College of Pharmacy, Kanpur Uttar Pradesh India.
  • Suruchi Agarwal Dayanand Dinanath college Institute of Pharmacy.
  • Saurabh Kushwaha Dayanand Dinanath college Institute of Pharmacy
  • Anupam Kr. Sachan Dayanand Dinanath college Institute of Pharmacy

Abstract

You may agree with us when we say that the pharmaceutical business is not an easy one. It can prove to be quite a task to adapt to the changing healthcare standards, changing production requirements, changing government regulations, and incorporating the latest innovative technologies in the production process of drugs and medicines.

Also, the competition is huge in the pharmaceutical business, and you can’t sustain long in the business if you cannot offer the best quality medicines to the customers at truly competitive prices.

The whole pharmaceutical area needed various innovative and scientific solutions to solve the current problems related to cGMP practices, production, documentation, regulatory body requirements (US FDA, WHO, EU-GMP, PICS), quality of product, etc. Installing such software will help the Pharma industry to improve its cGMP practices and fulfill regulatory body’s requirements. It also covers the importance and their need in the Pharma industry. It also covers the meaning of software used in the pharmaceutical industry.

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Keywords:

Computer system software, cGMP practices, regulatory body’s requirements, quality of product

Published

2023-09-15

How to Cite

1.
Kumari M, Dubey A, Agarwal S, Kushwaha S, Sachan AK. Recent Technology and Software for GDP in the Pharmaceutical Industry. Scopus Indexed [Internet]. 2023 Sep. 15 [cited 2024 Feb. 26];16(5):7004-7. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/2836

References

Batool Nassir Hamran, Ahmed Fadhil Khudhair. Micellar Determination of Amoxicillin in the Pharmaceutical Compounds by using Cloud Point Extraction. Research J. Pharm. and Tech 2020; 13(2):732-741. doi: 10.5958/0974-360X.2020.00139.0

Reddy DS, Reddy T. Pharmaceutical and biotechnological applications of Transgenic Technology. International Journal of Pharmaceutical Sciences and Nanotechnology. 2018;11(4):4145–53. doi:10.37285/ijpsn.2018.11.4.1

Charoo NA, Ali AA. Quality Risk Management in pharmaceutical development. Drug Development and Industrial Pharmacy. 2012;39(7):947–60. doi:10.3109/03639045.2012.699065.

Chouthri D, Jawahar N, Mythili L, Radhakrishnan A. Spray Technology: A novel approach in Transdermal Drug Delivery. Research Journal of Pharmacy and Technology. 2020;13(2):1015. doi:10.5958/0974-360x.2020.00188.2

Windle, Terence Leslie William, (born 15 Jan. 1926), director, Directorate General for Agriculture, European Commission, 1980–91. Who’s Who. 2007; doi:10.1093/ww/9780199540884. 013.u40351.

Windle, Terence Leslie William, (born 15 Jan. 1926), director, Directorate General for Agriculture, European Commission, 1980–91. Who’s Who. 2007; doi:10.1093/ww/9780199540884. 013.u40351

Status and applicability of U.S. regulations: Current good manufacturing practices in manufacturing, processing, packaging, and holding of drugs’ (2016) Good Manufacturing Practices for Pharmaceuticals, pp. 19–30. doi:10.3109/9781420020939-4

Sweet S. Automated Interactive Simulation Model (AISIM) VAX version 50 version description document. 1987; doi:10.21236/ada189364

Godge RK, Shinde GS, Bhosale MS. RP-HPLC method for estimation of Alogliptin and glibenclamide in synthetic mixture. Research Journal of Pharmacy and Technology. 2020;13(2):555. doi:10.5958/0974-360x.2020.00104.3

FDA issues draft guidance on providing more information on investigational treatment. PsycEXTRA Dataset. 2004;

doi:10.1037/e362152004-001.

Summary of the federal action plan on antimicrobial resistance and use in Canada. Canada Communicable Disease Report. 2015;41(S4): 1doi:10.14745/ccdr.v41is4a05

Munson J, Freeman Stanfield C, Gujral B. A review of Process Analytical Technology (PAT) in the U.S. Pharmaceutical Industry. Current Pharmaceutical Analysis. 2006; 2(4): 405–14.

doi:10.2174/157341206778699582

Hoffmann A, Kähny-Simonius J, Plattner M, Schmidli-Vckovski V, Kronseder C. Computer system validation: An overview of official requirements and standards. Pharmaceutica Acta Helvetiae. 1998;72(6):317–25. doi:10.1016/s0031-6865(97)00028-9

Anil Kumar S, Ramesh A. Antiulcerogenic activity of yttrium and copper oxide nanoparticles. International Journal of Research in Pharmaceutical Sciences. 2021;12(3):1803–7. doi:10.26452/ijrps.v12i3.4783

Arifin DY, Lee LY, Wang C-H. Mathematical modelling and simulation of drug release from microspheres: Implications to drug delivery systems. Advanced Drug Delivery Reviews. 2006;58(12–13):1274–325. doi:10.1016/j.addr.2006.09.007

Tibaut A, Rebolj D, Nekrep Perc M. Interoperability requirements for automated manufacturing systems in construction. Journal of Intelligent Manufacturing. 2014; 27(1): 251–62. doi:10.1007/s10845-013-0862-7.

Jeffery GH. Bassett J. Mendham J. and. Denny RC Editors. Vogel’s (2018). Text Book of Quantitative Chemical Analysis pp 4-906

Mannan A, Mubeen H. Digitalisation and automation in pharmaceuticals from drug discovery to Drug Administration. International Journal of Pharmacy and Pharmaceutical Sciences. 2018; 10(6): 1. doi:10.22159/ijpps.2018v10i6.24757

Rantanen J, Khinast J. The Future of Pharmaceutical Manufacturing Sciences. Journal of Pharmaceutical Sciences. 2015;104(11):3612–38. doi:10.1002/jps.24594

Kumar K. Data Integrity in pharmaceutical industry. Journal of Analytical & Pharmaceutical Research. 2016; 2(6). doi:10.15406/japlr.2016.02.00040

Luzzini D, Caniato F, Spina G. Designing Vendor Evaluation Systems: An empirical analysis. Journal of Purchasing and Supply Management. 2014;20(2):113–29. doi:10.1016/j.pursup.2014.03.002

Mali P, Panchal S. A review on Worldwide Essential Software Resources in Pharmacy. Chronicles of Young Scientists. 2011;2(1):11. doi:10.4103/2229-5186.79344

Parthiban P, Zubar HA, Katakar P. Vendor selection problem: A multi-criteria approach based on strategic decisions. International Journal of Production Research. 2013; 51(5): 1535–48. doi:10.1080/00207543.2012.709644

Prada R, Payandeh S. On study of design and implementation of virtual fixtures. Virtual Reality. 2009;13(2):117–29. doi:10.1007/s10055-009-0115-4

Upadhyay P. The role of verification and validation in system development life cycle. IOSR Journal of Computer Engineering. 2012; 5(1): 17–20.

doi:10.9790/0661-0511720

Appendix V: 21 code of U.S. federal regulations parts 210 and 211 current good manufacturing practice regulations. Establishing a CGMP Laboratory Audit System. 2006; 236–67.

doi:10.1002/0471784788

Baghel US, Sharma H, Chouhan A, Sharma A, Mukim M, Singh D. Gradient RP-HPLC method development for simultaneous estimation of dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride in liquid dosage form. Research Journal of Pharmacy and Technology. 2020;13(2):583. doi:10.5958/0974-360x.2020.00110.9

Mudd Krishna BS, Krishna TV, Kumar L, Reddy MS, Girish T, Pai KG. Personnel Hygiene in pharmaceuticals: Its importance and requirements for personnel involved in the manufacturing of Quality Medicines. Research Journal of Pharmacy and Technology. 2016;9(10):1647. doi:10.5958/0974-360x.2016.00331.0

Singh A, Singour P, Singh P. Computer system validation in the perspective of the pharmaceutical industry. Journal of Drug Delivery and Therapeutics. 2018;8(6-s):359–65. doi:10.22270/jddt. v8i6-s.2102

Moorthy VS, Roth C, Oliar P, Dye C, Kieny MP. Best practices for sharing information through Data Platforms: Establishing the principles. Bulletin of the World Health Organization. 2016;94(4). doi:10.2471/blt.16.172882