GMP and cGMP very common terms for almost all pharmaceutical professionals . GMP refers to good manufacturing practices and cGMP refers to current good manufacturing practices .
GMP and cGMP
These terms are most widely misunderstood terms among the pharmaceutical professionals worldwide in this article we will resolve the misconceptions regarding the concepts .
ACTUALLY GMP ARE THE GUIDELINES AND CGMP ARE THE REGULATIONS
let us exemplify the difference between guidelines and regulations the government has given the guideline to walk on right side of road it will be safer for us if we will follow the guideline or either we can also walk on left side . But the regulation is we have to stop on red light . that’s the difference .
Guidelines are given by the government for pharmaceuticals which if followed is good to take approvals or another approach for the same thing could be taken whichever the company thinks is better
Regulations
But the Regulations must be followed .
Another major difference is cGMP term is only used by the FDA(Food and drug administration) for rest of countries the GMP and cGMP are same .
only FDA has specified different definitions for 21 CFR for GMP and cGMP
21 CFR defines GMP as A GMP is a system to ensure that products manufactured are consistently produced and controlled in accordance to sufficient quality standards.
21 CFR define cGMP as regulations enforced by the US Food and Drug Administration (FDA) to comply with latest standards and technologies to improve the process as well as facilities .
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