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THAILAND |
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Authority |
FDA-DCD (Drug control Division) |
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website |
www.fda.moph.go.th/eng/drug/index.stm |
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if any |
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REQUIREMENT FOR PRODUCT REGISTRATION |
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INDEX |
Page. No |
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PART – I: Administrative part |
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composition |
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Labels and cartons |
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Pack inserts |
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CoA of finished product |
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CPP certificate |
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GMP certificate |
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PART – II: Active Pharmaceutical Ingredient part |
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S. Drug Substance |
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S1. |
General Information |
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S1.1 |
Nomenclature |
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S1.2 |
Structure |
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S1.3 |
General Properties |
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S2 |
Manufacture |
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S2.1 |
Manufacturer(s): Name and address |
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S3 |
Characterization |
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S3.1 |
Elucidation of Structure and other Characteristics |
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S3.2 |
Impurities |
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S4 |
Control of (API) |
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S4.1 |
Specification and Certificate of Analysis |
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Analytical Procedures |
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S4.3 |
Validation of Analytical Procedures |
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S5 |
Reference Standards of Materials |
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S6 |
Stability summary and conclusion |
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S7 |
Stability data |
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PART – III : Finished dosage part |
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P: DRUG PRODUCT |
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P1 |
Description and Composition of the Drug Product |
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P2 |
Pharmaceutical Development |
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Components of the Drug Product |
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Active Ingredient |
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Inactive Ingredient |
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Finished Dosage |
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Formulation Development |
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Ovarages |
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Physiochemical and biological properties |
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P2.3 |
Container Closure System |
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P2.4 |
Microbiological Attributes |
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P2.5 |
Compatibility |
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P3 |
Manufacture |
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P3.1 |
Batch Formula |
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P3.2 |
Manufacturing Process And Process Controls |
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P3.3 |
Control of Critical steps and intermediates |
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P3.4 |
Process validation and/or evaluation |
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P4 |
Control of Excipients |
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P4.1 |
Specifications |
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P4.2 |
Analytical procedures |
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P4.3 |
Excipients of human and animal origin |
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P5 |
Control of Drug Product (Finished Product) |
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P5.1 |
Specification and certificate of analysis |
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P5.2 |
Analytical Procedures |
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P5.3 |
Validation of Analytical Procedures |
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P5.4 |
Batch Analyses |
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P5.5 |
Characteristics of Impurities |
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P5.6 |
Justification of Specifications |
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P6 |
Reference Standards of Materials |
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P7 |
Container Closure System |
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P8 |
Stability data |
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Stability summary and conclusion |
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Post approval stability protocol and stability commitment |
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Stability data |
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PART IV :Product Interchangeability/BE study. |
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Toc for thailand, toc formate for product registration
S4.2