An Overview of GMP Requirements for Drug Product in China

Authors

  • Achin jain Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore, India
  • Jayant Kumar Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore, India
  • M.P. Venkatesh Pharmaceutical Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore, India

DOI:

https://doi.org/10.37591/rrjodfdp.v3i2.339

Abstract

Good manufacturing practice (GMP) is a tool which facilitates the innovation and continual improvement throughout the lifecycle of products and strengthens 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 which improves the health of the individual patient and the community. The main objective of this study was to compile the key GMP requirements for manufacture of generic product in China.

 

Keywords: Good manufacturing practice (GMP), The State Food and Drug Administration (SFDA), China

Cite this Article

Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Drug Product in China. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 1–6p.

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Published

2019-02-27

Issue

Vol. 3 No. 2 (2016)

Section

Review Article

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