Active Pharmaceutical ingredient FOR GENERICS

1. Active Pharmaceutical ingredient FOR GENERICS Presented By: Dr. Zeba Ahmed Shuja Director Technical, Schazoo Zaka Pvt. Ltd.

2. Active Pharmaceutical ingredient WHO Requirements: API: • API Name • Nomenclature • Recommended INN • Compendial name • Chemical name • Other non proprietary name • CAS registry number DRAP Requirements: API: • API Name • No information required regarding chemical name etc.

3. Active Pharmaceutical ingredient WHO Requirements: • API Structure • Structural formula • Molecular formula • Molecular weight • General properties • Physical description • Solubility • Physical form • Stereochemistry polymorphism DRAP Requirements: • No information is required regarding structure of the API, Molecular formula, or stereochemistry or polymorphism.

4. Active Pharmaceutical ingredient WHO Requirements: • Control of API • API specifications of API and FPP manufacturer • Container/ Closure system DRAP Requirements: • API specifications of FPP manufacturer is required • No information required regarding container/closure system.

5. Active Pharmaceutical ingredient WHO Requirements: • Stability of API • Stability summary & conclusion • Proposed storage condition & retest period DRAP Requirements: • No data regarding stability of the API is required like stability summary, proposed storage condition etc of the API.

6. Active Pharmaceutical ingredient WHO Requirements: • API Manufacturer • Name, address & responsibility (certificate of suitability , API master file) • Manufacturing authorization for production of API • Description of manufacturing process and process controls DRAP Requirements: • No information regarding API manufacturing and manufacturing process is required.

7. Active Pharmaceutical ingredient • WHO Requirements: • Manufacturing process flow diagram • Brief description of the manufacturing process DRAP Requirements: • No flow diagram, or description of the manufacturing process is required.

8. Active Pharmaceutical ingredient WHO Requirements: • Control of Materials • Summary of the quality and controls of the starting materials • Name and manufacturing site address of starting material manufacturer(s): DRAP Requirements: • No information related to control of materials, Summary of the quality and controls of the starting materials is required etc

9. Active Pharmaceutical ingredient WHO Requirements: • Controls of Critical Steps and Intermediates • Process Validation and/or Evaluation • Manufacturing Process Development DRAP Requirements: • No information related to control of critical steps & intermediates, process validation, manufacturing process development etc.

10. Active Pharmaceutical ingredient WHO Requirements: • Characterisation • Elucidation of Structure and other Characteristics by IR, NMR or Mass spectroscopy. • Control of the API • Specification (API Specs of FPP manufacturer) DRAP Requirements: • No characterization data required as elucidation of structure, control of APIs, Analytical procedures, validation of analytical procedures etc.

11. Active Pharmaceutical ingredient WHO Requirements: • Validation of Analytical Procedure of API, • Validation of related substances, residual/impurities solvents of API • Batch Analyses of three consecutive batches DRAP Requirements: • Analytical method validation or batch analysis is not required

12. Active Pharmaceutical ingredient WHO Requirements: • Justification of Specification • Source of primary reference standards and its link to secondary and working standard • Container Closure System DRAP Requirements: • No such information regarding reference standard is required.

13. Active Pharmaceutical ingredient WHO Requirements: • Stability • Stability studies of 3 consecutive batches at acc./inter. & long term conditions, Stability Summary and Conclusions • Proposed storage statement and re-test period DRAP Requirements: • Only stability of FPP is required. No information is required about stability of API(s)

14. Active Pharmaceutical ingredient WHO Requirements: • Post-approval Stability Protocol and Stability Commitment • Stability Data • Actual stability results • Summary of analytical procedures and validation DRAP Requirements: • No stability data is required for API.