Quality control in the pharmaceutical industry

Abstract

The quality in the pharmaceutical industry has become a major concern and there has been a growing awareness for the significance of the quality of the pharmaceutical products. The current concept of Good Manufacturing Practices (GMP) emphasizes that the quality of pharmaceutical products must be constructed during the overall process cycle. Quality control department plays an important role since it demands the acquisition of reliable analytical data. Many important decisions are based on the analytical data of quality control department and it is important to have indication of the quality of these results. The current Pharmaceutical Industry is facing challenges for the manufacture of Chemical and Biological drugs for human and veterinary consumption as well as medical devices, traditional herbal products and cosmetics. Stringent GMPs are being followed for blood and its derivative as well as controlled manufacturing for Traditional Herbal Medicines, Cosmetics, Food and Dietary products which was otherwise differently a century before. Each regulatory system had faced certain circumstances which led to current well-defined controlled regulatory framework. This has resulted into improvisation of systematic manufacturing and marketing of safe, efficacious and qualitative drugs. With the growth of industry, the legislations from each region have become more and more complex and created a demand for the need for regulatory professionals to understand and solve the critical quality control issues in the Pharmaceutical Industries around the globe. The present study examines the current status of quality related issues in the pharmaceutical industry with the objectives of assessing the nature and intensity of such challenges, identifying gaps and design of policies.