Property | Value |
Name | Compilation of key GMP requirements in India and EU for tablet manufacturing companies |
Description | Review article:- I.N. Krishna Teja, N. Vishal Gupta*, Srirupa Biswas, H.V. Gangadharappa, T.M. Pramod Kumar, M. Sujith Kumar . Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore – 570015, Karnataka, India.
Abstract:-The objective of this study was to compile GMP requirements for tablet manufacturing facilities of regulated countries and rest of the world countries. GMP covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to staff. Detailed written procedures are essential for each process of manufacturing of tablet that could affect the quality of the finished product. Implementation of GMP is an investment in good quality medicines. This will improve the health of the individual patient and the community, as well as benefiting the pharmaceutical industry and health professionals. This work helps in bringing the awareness about the manufacturing requirements as per India and EU. It demonstrates industry and regulatory authority’s support for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health. Implementation of GMP throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. It also helps in increasing the process efficiency and product quality by adopting the current, risk-based manufacturing approach and in turn optimizes manufacturing process and improves quality of the end-product.
Keywords:-GMP, Tablet, India, EU. |
Filename | Gupta Vishal et. al..pdf |
Filesize | 176.16 kB |
Filetype | pdf (Mime Type: application/pdf) |
Creator | admin |
Created On: | 10/17/2011 00:00 |
Viewers | Everybody |
Maintained by | Editor |
Hits | 13181 Hits |
Last updated on | 11/16/2011 20:58 |
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