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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 12
First page : ( 6124) Last page : ( 6132)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.01064.3

A Research on effective Management of Manufacturing defects to avoid Product Recalls: A Challenge to Pharmaceutical Industry

Abhinaya N.1,*, Thunga Girish2, Muddukrishna B S3, Pai Raveendra4, Shenoy U. Ravindra5, Khan Sohil6, Pai K Girish1,**

1Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104

2Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104

3Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104

4Formulation Development, Glenmark Pharmaceuticals Limited, M-4, Taloja MIDC, Panvel, Raigarh Dist, India-410208

5Department of Commerce, Manipal Academy of Higher Education, Manipal, Karnataka, India-576104

6Pharmacotherapeutics and Evidence Based Practice School of Pharmacy and Pharmacology, Griffith University, 4222, Queensland, Australia

*Corresponding Author E-mail: abhinayanayak@gmail.com

**girish.pai@manipal.edu

Online published on 24 February, 2020.

Abstract

Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) forms the backbone of any professionally managed pharmaceutical industry. Despite having GMP systems and SOPs in place, regulators/FDAs are finding faults and wrong doing by pharmaceutical firms and identify the manufacturing defects in marketed brand or generic medicines which ultimately leads to product recall from the market. The purpose of this study was to investigate the quality issues of different solid dosage forms collected from hospital pharmacy/retail outlets. Few captured quality issues include Multivitamin Tablets, Omeprazole magnesium & Domperidone Tablets, Glibenclamide & Metformin Tablets, Desloratadine Tablets, Hydroxyurea Capsules, Primose oil & Vitamin E gelatin capsules and carried out thorough investigation. The physical examination yielded few critical and major defects in the solid oral dosage form. The various defects, probable root causes were investigated, and remediation was suggested in each of the cases. Clinical significance of each case was also analysed. Recently, product recalls issues are becoming major threat of doing business in regulated markets. The studied quality issues are prime reasons for product recalls. Product recalls damages the reputation, patient's perception about company/generic brand and these companies will have a negative impact. Quality is the responsibility of all personnel involved in manufacturing a product, its testing and release. A strong Quality Assurance (QA) system with commitment for quality at plant level will reflect positively on product quality resulting in a product with zero defects.

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Keywords

Manufacturing defects, Product recalls, Good Manufacturing Practices (GMPs), Investigation, Tablets, and Capsules.

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