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India’s Updated GMP for Drug Makers

India's Updated GMP for Drug Makers mind map
Recent News
Notified by Union Health Ministry
Revised under Schedule M
When
Notified in 2024
Why
Ensure robust quality control
Minimize pharmaceutical risks
Align with global standards
What
GMP System
Ensures product quality
Minimizes production risks
Follows WHO guidelines
Revised Schedule M
Incorporates WHO-GMP
Introduced in 1988
Last amendment in 2005
Major Changes
Pharmaceutical Quality System (PQS)
Quality Risk Management (QRM)
Product Quality Review (PQR)
Equipment Validation
Computerized Storage Systems
Where
India
Who
Union Health Ministry
Pharmaceutical Companies
WHO (World Health Organization)
How
Implementation timeline
6 months for large companies
12 months for smaller companies
Revised guidelines
Emphasis on quality management
Regular quality reviews
Computerized process management
Significance
Enhances medicine quality
Aligns with international standards
Improves patient outcomes
Boosts industry reputation
Challenges
Implementation challenges
Scale and cost for smaller units
Compliance within deadlines
Global market expectations
Way Forward
Continuing to align with global standards
Enhancing quality control and documentation
Promoting high-quality production

India’s Updated Good Manufacturing Practices (GMP) for Drug Makers, notified in 2024 by the Union Health Ministry, mark a significant revision of the existing standards under Schedule M of the Drugs and Cosmetics Rules. The update aims to ensure robust quality control in pharmaceutical production, aligning India’s standards with global norms, especially those of the World Health Organization (WHO). Major changes include the introduction of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), validation of equipment, and computerized storage systems. The revisions require large companies to implement these changes within six months and smaller companies within a year. This move is expected to elevate the quality of medicines, improve patient outcomes, and enhance the reputation of the Indian pharmaceutical industry on a global scale.

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