cGMP stands for current Good Manufacturing Practices. It is a set of regulations and guidelines enforced by regulatory authorities like the FDA (U.S. Food and Drug Administration) and other global agencies to ensure that pharmaceutical products are consistently produced and controlled according to quality standards.
🔍 What Does cGMP Ensure?
cGMP ensures:
✅ Product quality
✅ Safety
✅ Efficacy
✅ Consistency in manufacturing processes
📌 Key Principles of cGMP
1. Hygiene and Cleanliness – Clean environment and personnel.
2. Qualified Equipment and Facilities – Verified for proper functioning.
3. Documented Processes – SOPs (Standard Operating Procedures) must be followed.
4. Trained Personnel – Workers must be competent and trained.
5. Validation and Testing – Processes and equipment are validated; products are tested
6. Change Control and CAPA – Proper handling of changes and corrective actions.
🏠Why is “current” Important in cGMP?
The “current” in cGMP reminds manufacturers to keep up-to-date with the latest technologies, systems, and practices to maintain product quality
đź“– cGMP is Mandatory for:
Pharmaceuticals
Biologics
Medical Devices
Food and dietary supplements
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