Stability.ppt

World Health Organization Evaluation of Quality and Interchangeability of Medicinal Products Finished Pharmaceutical Products Stability/Shelf-life specification Matrixing and bracketing Presenter: Deus K. Mubangizi, pharmacist, MSc(Pharm.) deuskm@yahoo.co.uk, dmubangizi@nda.or.ug Chief Inspector of Drugs, National Drug Authority WHO expert Quality dossier / Section 3Finished Pharmaceutical Product (FPP) 3.1. Manufacturing and marketing authorization 3.2. Pharmaceutical development 3.3. Formulation 3.4. Sites of manufacture 3.5. Manufacturing process 3.6. Manufacturing process controls of Critical steps and intermediates 3.7. Process validation and Evaluation 3.8. Specifications for excipients 3.9. Control of the FPP 3.10. Container/closure system (s) and other packaging 3.11. Stability testing Quality dossier / Section 3Finished Pharmaceutical Product (FPP) 3.12. Container labelling 3.13. Product information for health professionals 3.14. Patient information and package leaflet 3.15. Justification for any differences to the product in the country or countries issuing the submitted WHO-type certificate(s) Quality dossier / Section 3Finished Pharmaceutical Product (FPP) 3.11. Stability testing The purpose of stability testing is to provide evidence on how the quality of a FPP varies with time under the influence of a variety of environmental conditions such as temperature, humidity and light and to establish a shelf-life for the FPP, to determine the storage conditions and the in-use stability. To know about length of the time and conditions where efficacy, safety and quality of the FPP are maintained Quality dossier / Section 3Finished Pharmaceutical Product (FPP) 3.11. Stability testing Lots included in the study: 1 production batch and 2 of pilot scale manufactured according to the process described in the dossier Pilot scale batch for solid dosage forms is 10% of production scale or 100 000 whichever is greater Parameters suscep