cGMP considerations for parenteral formulations | 30398
Journal of Pharmaceutical Care & Health Systems

Journal of Pharmaceutical Care & Health Systems
Open Access

ISSN: 2376-0419

cGMP considerations for parenteral formulations

Pharmaceutical Summit and Expo

October 08-10, 2015 New Delhi, India

Praful D Bharadia

Indore Institute of Pharmacy, India

Posters-Accepted Abstracts: J Pharma Care Health Sys

Abstract :

Pharmaceutical formulations have evolved from simple products to sophisticated devices and delivery systems over the last decade. Continuous efforts to make cost effective and safe medicines has always been the forefront of the Indian pharmaceutical industry. Technological advances in the areas of design, manufacturing technology, quality testing, and regulatory compliance of Pharmaceuticals has become challenging. Current Good Manufacturing Practices (cGMP) assist the industry in developing sustainable strategies for quality processes. It has been interestingly observed that the number of batches failing in quality as per regulatory standards has not decreased over the years. Looking at the USFDA recalls it is clear that cGMP violations accounts for the majority of failures. This has led to a lot of introspection. Parenteral products are more vulnerable since they require stringent manufacturing controls to prevent product failure. Problems of particulate matter and sterility account for major reasons. An in-depth study of product recalls was carried out and the causes of failure were classified. Data obtained was analyzed and grouped to assess the findings. Correlation was established as to which cGMP violations were responsible for product failure. Class I, II and III recalls were also correlated with the reasons of product failure. The findings have been tabulated and presented.

Biography :