Pharmaceutical Quality Information Form (ppt Jan 2006)

http://mednet3.who.int/prequal/pq_pres/workshop_China_Jan2006/PQIF-API.ppt

 

 

Guideline on Submission of Documentation for Prequalification of Multi-Source (Generic) Finished Pharmaceutical Products (FPPs) Used in the Treatment of HIV / AIDS, Malaria and Tuberculosis [GuideGeneric]

Guideline on Active Substance Master File Procedure [CPMP/QWP/227/02 Rev 1]

Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier [CPMP/QWP/297/97 Rev 1 corr]

ICH Q3A [R] Impurities Testing Guideline: Impurities in New Drug Substances [CPMP/ICH/2737/99]

ICH Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances [CPMP/ICH/367/96 corr]

ICH Q2A Validation of Analytical Procedures: Definitions and Terminology [CPMP/ICH/381/95]

ICH Q2B Validation of Analytical Procedures: Methodology [CPMP/ICH/281/95]

 

 

Properties of API

Route of Synthesis

Specifications