RegistrationrequirementofstabilitytestforPharmainChinaandcomparedwithVICH教程.pptVIP

* * * * * * Registration requirement of stability testing for Pharma in China compared with VICH Xia Lijun May 24, 2012 Beijing Content VICH VICH Guidelines for stability testing Stability testing design in China compared with VICH Bracketing and Matrixing design in VICH registration requirement for stability report in China * VICH Guidelines for Stability testing * VICH is a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for veterinary product registration. VICH guidelines for Stability testing: VICH GL3(STABILITY 1),May 1999: New Veterinary drug substance and Medicinal product VICH GL3(R),Jan 2007: New Veterinary drug substance (Revision) VICH GL4(STABILITY 2 ), May 1999: New Veterinary dosage forms VICH GL5(STABILITY 3),May 1999: Photostability testing of New Veterinary drug substance and Medicinal product VICH GL45 –Bracketing and Matrixing ,Apr 2010: New Veterinary drug substance and Medicinal product Stability test design * New veterinary drug substances Stress testing Temperature Humidity Photolysis Accelerated testing Long-term testing New Medicinal products Stress testing Photolysis Accelerated testing Long-term testing Use condition stability VICH-Intermidate testing pH,oxide,freezing Stability test design-selection of batches * for each presentation and strength: Stress testing—1 batch Accelerated testing—3 batches Long-term testing—3 batches VICH-Stability should be performed on each individual strength and container size of the drug product unless bracketing or matrixing (reduced design) is applied. Stability test design Container Closure System: proposed for marketing * Specification: shelf-life criteria,test items and acceptable limits. Certifect: spon on solution appearance,clear,assay,impurity…… Previcox: tablet appearance,assay,impurity,dissolution…… II Sub-tropical: China,USA,France,Japan etc Photolysis(4500±500LX) Accelerated (40±2℃,RH75%±