The Stability Report Requirements for：稳定性报告要求.doc

File content of Stability Study ( )File content in case of stability study of OLD SYSTEM 1-Covering letter of the file contents.2-Copy of composition.3-Method of analysis for stability for finished products.4-Copy of certificate of analysis from NODCAR.5-Complete stability report with tables for 3batches (accelerated or long term).6- Copy from certificate of analysis from company. 7-Chromatograms of HPLC analysis of each time interval for all batches( at least for last time interval) 8-Method of validation of Analytical procedures for finished product with the HPLC Charts for each parameter . 9- .In Case of Re- registration: add the following items: - - Document from on going stability studies for at least one batch /year for surveillance period (shelf period).- Original pack with the shelf life& storage conditions In Case of Imported Products: add the following items: - Copy from the Source CPP confirms the Shelf life & storage conditions ( shelf life in the country of origin.)- Original pack with the shelf life& storage conditions File content in case of stability study of NEW SYSTEM (first representation)1-Covering letter of the file contents.2-Copy of composition (on company paper)3-Method of analysis for stability for finished products.4-Accelerated stability study on one (R & D batch )at least for four time intervals.5- Copy from certificate of analysis from company.6- Chromatograms of HPLC analysis of each time interval. 7-Method of validation of Analytical procedures for finished product with the HPLC Charts for each parameter . 8- . 9-WHO format on the company paper (stamped). 10-Arabic & English leaflet +reference 11-Colored pack+pack of the innovator. 12-Copy of application. 13-Copy of pricing committee approval.(second representation)1-Covering letter of the file contents.2-Copy of composition (on company paper)3-Method of analysis for stability for finished products.4-Accelerated stability study on one (Production batch )at least for four time intervals.5- Copy from certificate of analysis from company.6- Chromatograms of HPLC analysis of each time interval. 7-Method of validation of Analytical procedures for finished product with the HPLC Charts for each parameter 8 - 9-WHO format on the company paper (stamped).10- Copy of certificate of analysis from NODCAR. 11-Original pack .12- File content in case of SHELF LIFE EXTENSION:1-Covering letter explains the reason.2-Copy of composition.3- 4-Long term stability study for 3 batches . 5-Method of analysis for stability for finished products. 6-Chromatograms of HPLC analysis of at least the end of Shelf life. 7-Method of validation of Analytical procedures for finished product with the HPLC Charts for each parameter (for one batch). 8-Copy from the Source CPP confirms the Shelf life & storage conditions ( shelf life in the country of origin.) 9-Pack with the shelf life& storage conditions.File content in case of SHELF LIFE DECREASE:1-Covering letter explains the reason.2- 3. Copy from the Source CPP confirms the Shelf life & storage conditions ( shelf life in the country of origin.) 4-Pack with the shelf life& storage conditions .File content in case of CHANGE OF STORAGE CONDITIONS: 1-Covering letter explains the reason.2-Copy of composition.3- 4-Long term stability study for 3 batches.5-Method of analysis for stability for finished products.6-Chromatograms of HPLC analysis of at least the end of Shelf life. 7-Pack with the shelf life& storage conditions.File content in case of CHANGE OF THE PACK:1-Covering letter explains the reason.2-Copy of composition.3- 4-Accelerated & or Long term stability study for 3 batches.5-Method of analysis for stability for finished products.6-Chromatograms of HPLC analysis of at least the end of Shelf life. 7-Pack with the shelf life& storage conditions.8- . ( ) :File content in case of this case:1-Covering litter of the file contents.2-Copy of composition.3- Method of analysis for stability for finished pr