Quality Assurance Documentation and Records: Harmonized GMP Requirements
2011
Quality Assurance Documentation and Records: Harmonized GMP Requirements
publication
Author Information
Author(s): KT Patel, NP Chotai
Primary Institution: Torrent Pharmaceuticals Ltd., R and D Center, Bhat, Ghandhinagar, India
Conclusion
Effective documentation is essential for ensuring compliance with good manufacturing practices (GMP) and enhances the visibility of the quality assurance system.
Supporting Evidence
- Documentation helps to build a detailed picture of manufacturing functions.
- Regulatory inspectors spend significant time examining a company’s documents.
- Good documentation prevents errors resulting from spoken communication.
Takeaway
This study explains that keeping good records is very important in making sure medicines are safe and made correctly. If something isn't written down, it didn't happen!
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