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Research, Development, and Manufacture of Investigational Drugs
Manual for Soft Capsule Development
1. Process of Soft Capsule Development (Product Consignments)
New drug development research
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Research development for generic medicines and non-prescription drugs
Development of early phase prototype drug product
*Study of fill material formulation *Study of capsule shell formulation
*Sample production *Drug stability testing
Development of prototype drug product
*Sample production *Specifications *Drug stability testing
Examination of final determination of formulation
*Sample production *Specifications *Drug stability testing
Examination of final determination of formulation
*Sample production *Drug stability testing
Examination of manufacturing of drug product using the final formulation
*Sample production *Drug stability testing *GMP validation
Increase in production scale
*Manufacture of investigational drugs * Investigational drug GMP
Manufacturing process validation
*GMP validation (full-scale production)
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Research development for prescription drugsand non-prescription drugs
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