Author(s): Anali Sawant, Seema Kamath, Hemanth Katta G, Muddukrishna Badamane Sathyanarayana, Ravindra Shenoy, Girish Pai K

Email(s): girish.pai@manipal.edu

DOI: 10.52711/0974-360X.2022.00121   

Address: Anali Sawant1, Seema Kamath1, Hemanth Katta G1, Muddukrishna Badamane Sathyanarayana2, Ravindra Shenoy3, Girish Pai K1*
1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India.
2Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India.
3Department of Commerce, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka, 576104, India.
*Corresponding Author

Published In:   Volume - 15,      Issue - 2,     Year - 2022


ABSTRACT:
Any medicinal product introduced in the market ought to have the highest safety, quality, purity and efficacy as it is received by an ailing patient. Parenteral products are sterile pharmaceutical preparations that are injected, infused or implanted in the body. These products must maintain their quality and sterility as they are introduced directly into the bloodstream. Negligence associated with parenteral preparations can lead to severe or fatal adverse events. Although each country has its own regulatory body to keep a check on medication errors, defects keep occurring in pharmaceutical products. It should be the top priority of pharmaceutical companies to avoid these defects and related issues. This study focuses on three such real life defective parenteral products obtained from the hospital pharmacy. The probable root cause, remediation and clinical significance of the noted defect is also mentioned. These case studies can help pharmaceutical manufacturers minimize defects, quality issues to avoid product recalls and to achieve better therapeutic compliance.


Cite this article:
Anali Sawant, Seema Kamath, Hemanth Katta G, Muddukrishna Badamane Sathyanarayana, Ravindra Shenoy, Girish Pai K. Investigation of manufacturing defects and cGMP lessons learnt from quality issues in Pharmaceutical Sterile Preparations. Research Journal of Pharmacy and Technology. 2022; 15(2):729-5. doi: 10.52711/0974-360X.2022.00121

Cite(Electronic):
Anali Sawant, Seema Kamath, Hemanth Katta G, Muddukrishna Badamane Sathyanarayana, Ravindra Shenoy, Girish Pai K. Investigation of manufacturing defects and cGMP lessons learnt from quality issues in Pharmaceutical Sterile Preparations. Research Journal of Pharmacy and Technology. 2022; 15(2):729-5. doi: 10.52711/0974-360X.2022.00121   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-2-41


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