GMP in pharma help use to achieve:
GMP in pharmaceuticals, prevents any substandard, adulterated and unsafe products from being introduced into both national and international markets.
GMP protects the consumer from purchasing a product that is not effective or even dangerous.
GMP regulations address issues including records keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation and complaint handling.
Implications of Non-compliance to GMP in pharma:
Failure of firms to comply with GMP regulations can result in very serious consequences including product recall, seizure, import ban, warning letters, fines, and jail time.
10 Principles of cGMP?
10 principles are covered in 3 categories.
Facility & equipment:
- Design facility and equipment
- Maintain facility and equipment
- Quality by design
Process & Procedures:
- Validate processes
- Write and follow good procedures
- Keep good records
Personnel & Training:
- Identify who does what
- Train and develop staff
- Practice good hygiene
- Perform regular audits
- 10 Principles of cGMP
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Refer to YT Channel: Pharmabeej