A GLANCE TO THE STORY OF GOOD MANUFACTURING PRACTICES FOR PHARMACEUTICALS

Jameela Helen Jacobs Jameela Helen Jacobs,Margret Chandira R Margret Chandira R,Deepu S Deepu S,Benny Kj Benny Kj

doi:10.32553/jbpr.v9i3.752

Jameela Helen Jacobs Jameela Helen Jacobs, Margret Chandira R Margret Chandira R + Show 2 more

Open Access

https://doi.org/10.32553/jbpr.v9i3.752

Copy DOI

Abstract

Good Manufacturing Process (GMP) is the magic key that opens the door of quality. GMP is an evergrowing process as the new drugs are discovering day by day, but the concept is not new; its roots are very old. Everyone in our industry should know the story of how the GMP has come to be. Most requirements were put in place as a result of tragic circumstances and to prevent future tragedies. These regulations are mandatory for drug manufacturing companies in order to manufacture quality products. Keywords: GMP, FDA, WHO

Highlights

Good Manufacturing Process (GMP) is the magic key that opens the door of quality
Everyone in our industry should know the story of how the GMP has come to be
Good manufacturing practice (GMP) refers to an international set of regulations planned for implementation in the pharmaceutical or drug industries to assure the effectiveness, quality and safety of drug/pharmaceutical products[1]

Summary

Introduction

Good manufacturing practice (GMP) refers to an international set of regulations planned for implementation in the pharmaceutical or drug industries to assure the effectiveness, quality and safety of drug/pharmaceutical products[1]. As a result FDA began to revise manufacturing and quality controls the beginning of this was called GMPs. The Public Health Services Act of 1944 has large area of concerns, which includes the regulation of biological products and the control of communicable diseases. The law provides for a system of preand post-market oversight, including FDA inspections, to ensure that companies follow GMPs, keep appropriate records on the design and manufacture of their products, and maintain system for handling complaints. These are the provisions we take for granted today. A glance of major points involved in the chronological development of GMP is notified

Conclusion

Findings

WHO Expert Committee on Specifications for Pharmaceutical