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anuradha mitra
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can anyone tell me how is the expiry date of a medicine determined?
How is the Expiry Date of Medicine Determined?
- Context: Medical
- Thread starter anuradha mitra
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- Medicine
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SUMMARY
The expiry date of medicine is determined through stability testing, which assesses how the quality of a drug varies with time under the influence of environmental factors such as temperature, humidity, and light. The World Health Organization (WHO) provides guidelines for conducting these stability studies, as outlined in their September 2006 document. Pharmaceutical companies must conduct these tests to ensure that the medicine maintains its efficacy and safety throughout its shelf life. The results of these studies inform the labeling of the expiry date for each specific medication.
PREREQUISITES- Understanding of pharmaceutical stability testing
- Familiarity with WHO guidelines on drug stability
- Knowledge of environmental factors affecting drug quality
- Basic principles of pharmacology and drug formulation
- Review the WHO Stability Guidelines from September 2006
- Research methods for conducting stability testing in pharmaceuticals
- Explore the impact of temperature and humidity on drug efficacy
- Learn about regulatory requirements for drug expiry labeling
Pharmaceutical researchers, quality assurance professionals, and regulatory affairs specialists involved in drug development and compliance will benefit from this discussion.
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