A REVIEW ARTICLE ON GOOD MANUFACTURING PRACTICES (ORANGE GUIDE)
Journal Title: Int J of Pharm Rev& Res - Year 2015, Vol 5, Issue 1
Abstract
The concept of good manufacturing practice (GMP) is well known to every pharmaceutical company in the world. The 'Orange Guide' was first published in 1971 and since then it has become the premier guide for everyone involved in the production of medical products, regularly republished with amendments as regulations and requirements evolve. The 'Orange Guide' is necessary reading for any qualified person who is involved in the manufacture or distribution of medicines, drugs or blood. A set of current, scientifically sound methods, practices or principles that are implemented and documented during product development and production to ensure consistent manufacture of safe, pure and potent products. cGMP is just a guideline, system and quality theme for compliance. It is just a way to build quality in a product. Improves productivity and minimizes rejection and mistakes. Designed to ensure that the entire process, from purchase of approved material through detailed, defined production processes, using approved facilities and trained personnel operating in well designed buildings through QC department to final distribution outlets. This results in the achievement of consistent and uniformly good quality products.
Authors and Affiliations
Kumar dinesh , Kamble PR
Keywords
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