Author(s):
Hemanth KG, Mahendra Joshi, Richa Dayaramani, Damodharan N, Ravindra Shenoy, Girish Pai K
Email(s):
girish.pai@manipal.edu
DOI:
10.5958/0974-360X.2020.00794.5 
Address:
Hemanth KG1, Mahendra Joshi2, Richa Dayaramani3, Damodharan N4, Ravindra Shenoy5, Girish Pai K1*
1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India.
2Research and Development, IDRS Labs Pvt. Ltd, Bangalore-560099, Karnataka India.
3Department of Pharmaceutical Quality Assurance, Khyathi College of Pharmacy, Palodiya, Ahmedabad-382115, Gujarat, India
4Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Tamil Nadu, India.
5Department of Commerce, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 9,
Year - 2020
ABSTRACT:
In treatment of diseases, Quality and safe medicines are required which would save the human lives. Pharmaceutical Industry is one of the sectors with most stringent guidelines since it deals with human lives. Defective products from this sector is least anticipated. Defective product is the one which couldn’t fulfill the need of customer and may possess some degree of risk if it is used. If such product is released into the market, there are few consequences which manufacturing company would go through. Though Global Regulatory authorities, ICH and WHO have laid guidelines, we aren’t successful in preventing even minor defects such as discrepancies in label specification. The objective of this review article is to briefly discuss about the Pharmaceutical defects, Real-life product defects compared to textbooks recorded defects, their consequences and recent voluntary product recalls published by US-FDA which could help the Pharmaceutical Industry in enhancing their quality system.
Cite this article:
Hemanth KG, Mahendra Joshi, Richa Dayaramani, Damodharan N, Ravindra Shenoy, Girish Pai K. Pharmaceutical Defects: A Critical Review on Defects of Various Dosage forms and Regulatory Impacts. Research J. Pharm. and Tech. 2020; 13(9):4505-4508. doi: 10.5958/0974-360X.2020.00794.5
Cite(Electronic):
Hemanth KG, Mahendra Joshi, Richa Dayaramani, Damodharan N, Ravindra Shenoy, Girish Pai K. Pharmaceutical Defects: A Critical Review on Defects of Various Dosage forms and Regulatory Impacts. Research J. Pharm. and Tech. 2020; 13(9):4505-4508. doi: 10.5958/0974-360X.2020.00794.5 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-9-82
REFERENCES:
1. Johann Wolfgang von Goethe-Certain defects are necessary. Available from: URL: https://www.brainyquote.com/ quotes/johann_wolfgang_von_goeth_150534
2. DEFECT | meaning in the Cambridge English Dictionary. Available from: URL: https://dictionary.cambridge.org/ dictionary/english/defect
3. Kumar L, Reddy S, Pydi C, T V, Krishna M, Pai K. A Research on Market Complaint Product: Detailed Investigation and a Report on Broken Film Coated Tablet inside an Intact Blister Pack. Lat Am J Pharm. 2018 Feb 9;37.
4. Krishna VT, Pai GK, Singh M, Kumar L, Reddy SM. Comparative Evaluation of Few Marketed products of Amoxicillin Trihydrate Dispersible Tablets IP. Asian J Pharm Clin Res. 2014;7 (2):109–10.
5. Mehta SB, Roy S, Yang H-C (Cathy). “Product on Stopper” in a Lyophilized Drug Product: Cosmetic Defect or a Product Quality Concern? J Pharm Sci. 107(6):1736–40. Available from: URL: https://linkinghub.elsevier.com/retrieve/pii/S0022354918300753
6. Tippavajhala VK. A Critical and Comparative Study on Patient Information Leaflet, Primary Label and Primary Carton of a Carbapenem Dry Powder Injectable. Indian J Pharm Educ Res. 2019;53(1):178–85.
7. Krishna TV, Kumar L, Reddy MS, Rao R, Ankineedu M, Pai KG. Investigation to find out the root cause for presence of broken tablet in the marketed blister pack. Res J Pharm Technol. 2015;8(6):707–9.
8. Abhinaya N, Thunga G, Muddukrishna B, Pai R, U RS, Khan S, et al. A Research on Effective Management of Manufacturing Defects to Avoid Product Recalls: A Challenge to Pharmaceutical Industry. Res J Pharm Technol;12 (12):6124–32. Available from: URL: http://rjptonline.org/AbstractView.aspx?PID=2019-12-12-87
9. Lachman L, Lieberman HA. The Theory and Practice of Industrial Pharmacy. 4th ed. CBS Publishers and Distributors Pvt Ltd; 2013. 488-492,522 p.
10. Tawde SA. Particulate Matter in Injectables: Main cause for Recalls. J Pharmacovigil;03(01). Available from: URL: http://www.esciencecentral.org/journals/particulate-matter-in-injectables-main-cause-for-recalls-2329-6887-3-e128.php?aid=39495
11. SOP on Market Complaint. PharmaState Blog. 2019. Available from: URL: https://pharmastate.blog/sop-on-market-complaint/
12. Krishna TV, Kumar L, Reddy MS, Muddukrishna B, Pai KG. Market Complaints in Pharmaceuticals: A Brief Review on its Handling, Investigation and Reporting. Res J Pharm Technol. 2013;6(11):1314–6.
13. Center for Devices and Radiological Health. Recalls, Corrections and Removals (Devices). FDA. FDA; 2019. Available from: URL: https://www.fda.gov/medical-devices/postmarket-requirements-devices/recalls-corrections-and-removals-devices
14. Center for Drug Evaluation and Research. FDA’s Role in Drug Recalls. FDA. 2018 Nov 3; Available from: URL: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls
15. Center for Drug Evaluation and Research. Drug Recalls. FDA. FDA; 2019. Available from: URL: https://www.fda.gov/drugs/ drug-safety-and-availability/drug-recalls
16. Bortoli L, Freundt V. Effects of Voluntary Product Recall on Consumer’s Trust. Braz Bus Rev. 2017 Mar 1;14(1):204–24. Available from: URL: http://bbronline.com.br/index.php/bbr/ article/view/36
17. Center for Drug Evaluation and Research. Q10 Pharmaceutical Quality System. 2009. Available from: URL: https://www. fda.gov/media/71553/download