A research on effective management of manufacturing defects to avoid product recalls: A challenge to pharmaceutical industry

N. Abhinaya, Girish Thunga, B. S. Muddukrishna, Raveendra Pai, U. Ravindra Shenoy, Sohil Khan, K. Girish Pai

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)6124-6132
Number of pages9
JournalResearch Journal of Pharmacy and Technology
Volume12
Issue number12
DOIs
Publication statusPublished - 12-2019

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Pharmacology (medical)

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