Good Manufacturing Practices: The Gap within...Dr. Manjusha Rajarshi

World Health Organization states in its manifesto that it is indeed necessary for all governments to ensure the availability and affordability of efficacious, safe and good quality medicines relevant to the health care needs.

WHO through its various programs helps governmental agencies across the world to implement the GMP norms in production. The GMP guidelines from ICH continue to guide regulators, manufacturers to help manufacture pharmaceutical products of high quality standards.

The mainstay of GMP is the 4M principle; Men, machines, material and manufacturing premises. All these 4Ms are equally important. The world scenario for GMP standards is varied; from the best to the worst is the scenario we find at different geographies of the world and it has great deal of importance with the national regulations, social issues and business and professional ethics.

We will just peep in the Indian scenario. The GMP guidelines are implemented in Indian legislation since 1980s; it is revised several times in hope to implement GMP standards to provide quality medicines to Indian citizens. Today, we have varied manufacturing premises with varied standards. We have GMP plants approved and inspected by the Indian authorities, US-FDA approved manufacturing plants; PICs approved plants and so on. We have different standards for the plants engaged in exports business (regulated markets ~ very high GMP standards) compared to exports to non-regulated markets and so on.

Why do we see such a gap? Is it that our legislation is lax or is it good legislation not implemented in the spirit and manner it needs to be done?

We need to look into all the aspects of the 4Ms to evaluate this disparity and more so bring in a self-disciplined approach in quest to provide safe, effective and quality medicines for human use and this can be best achieved by information sharing, training and implementation tactics.

Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives. ~ William A. Foster


Posted by Placement Manager IGMPI


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