alexa Abstract | Compilation of key GMP requirements in us and Japan for Tablet Manufacturing

International Journal of Drug Development and Research
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Abstract

The tablet is most popular dosage form in the world. The objective of this work helps in bringing the awareness about the manufacturing requirements as per USFDA and Japan. GMP covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to staff. GMP of tablet manufacturing was designed to ensure that all is well. Implementation of GMP is an investment in good quality medicines. 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.

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Author(s): Sujith Kumar M Vishal Gupta N BalamuralidharaV Srirupa Biswas T M Pramod Kumar Naga Krishna Teja I

Keywords

GMP, USFDA, Japan.

 
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