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
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.
Pharmaceutical Defects, ICH, Real-life products, Product recalls
