药学类骨干教师及基层药师培训 药学类骨干教师及基层药师培训 《浅谈质量源于设计》解读（张彦）.ppt

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * Stability Expectation For Generic Drugs Proposed Stability Guidance FDA is proposing to formalize its stability policies for ANDAs by adopting the recommendations in the ICH Q1 Stability Guidances Although the ICH stability guidances were intended to define what stability information should be provided in NDAs for a new drug substance or drug products, OGD believes the recommendations provided on stability testing are also appropriate for ANDAs * ICH Stability Guidances Q1A (R2) Stability Testing of New Drug Substances and Products (November 2003) Q1B Photostability Testing of New Drug Substances and Products (November 1996) Q1C Stability Testing for New Dosage Forms (November 1996) Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (January 2003) Q1E Evaluation of Stability Data (June 2004) * ICH Q1A Requirements: General Case (2.2.7.1) * If significant change occurs during 6 months’ testing at the accelerated condition, additional testing at the intermediate condition required Initial application should include a minimum of 6 months’ data from a 12-month study at the intermediate storage. ICH Q1A Requirement: Selection of Batches (2.2.3) * Stability studies data should be provided on at least three primary batches of the drug product. ?Two of the three batches should be at least pilot scale batches, and the third one can be smaller if justified.  ?Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied. ICH Q1A : Batch Definitions * ?Primary batch: A batch of a drug substance or drug product used in a formal stability study, from which stability data are submitted in a registration application for the purpose of establishing a retest period or shelf life, respectively. ?A primary batch may be a production batch. –Prod