Prequalification: Workshop

Planning, conduct and regulatory assessment of stability studies

       Accra, Ghana - 7-9 December 2009

The Training workshop focussing on stability testing of medicines was organized in cooperation with the Food and Drugs Board (FDB) of Ghana, for regulatory assessors and manufacturers from Ghana and Nigeria.  The training was attended by 57 participants, who were trained in technical requirements of WHO and ICH stability guidelines and practical issues relevant for the conduct and assessment of stability studies.

Programme [pdf]

Monday, 7 December 2009

• Regulatory requirements on medicine stability Guidelines relevant for stability testing, new WHO stability guideline

• Planning stability studies during product development, subcontracting [ppt]

• Qualification, calibration and maintenance of stability chambers [pdf]

• Analytical method development and validation [pptx]

• Stability of APIs (part 1 and part 2) [ppt]

Tuesday, 8 December 2009

• Stability studies of FPPs - conduct, bracketing and matrixing [ppt]

• Understanding and predicting product shelf-life [pdf]

• Stability studies - evaluation of outcomes and development of documentation for regulatory submissions [pptx]

• Stability of FPPs, including FDCs - standard date required by regulatory authorities [pdf]

• Post-approval stability data [pdf]

• Post-approval changes - variations [ppt]

• Stability data required by WHO Prequalification of Medicines Programme [ppt]

Wednesday, 9 December 2009

• Stability studies - regulatory evaluation and most frequently observed deficiencies - FDB experience [ppt]

• Stability studies - regulatory evaluation and most frequently observed deficiencies - Prequalification Programme [ppt]

• Stability studies - regulatory evaluation and most frequently observed deficiencies - Health Canada experience [ppt]

• Stability of antimalarial medicines [ppt]