An Overview of GMP Requirements for Generics in Brazil and Russia

Authors

  • Achin jain BeloorBayir Biotech Limited, Bangalore, India
  • Jayant Kumar CDSCO, New Delhi, 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.v3i2.340

Abstract

Implementation of good manufacturing practice (GMP) is an intelligent investment in building the good quality generics. It is the matter of fact that key GMP requirements for both generics and innovator drugs almost covers all aspects of production, from the starting materials, premises, equipment and training and personal hygiene to personnel. This work helps in bringing the awareness about the key GMP requirements for manufacturing of generics in Brazil and Russia—the two pharma emerging BRICS nation which in turn reduces the trade barrier for international commerce. It demonstrates industry support and regulatory authority’s commitment for an effective pharmaceutical quality system to enhance the quality and availability of medicines around the world in the interest of public health.

 

Keywords: BRICS, good manufacturing practice (GMP), generics manufacture, emerging market, Roszdranvadzor

Cite this Article

Kumar J, Jain A, Venkatesh MP. An Overview of GMP Requirements for Generics in Brazil and Russia. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(2): 7–14p.

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Published

2019-02-27

Issue

Vol. 3 No. 2 (2016)

Section

Review Article

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