INTRODUCTION
1.1 Objectives of the Guideline This guideline is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guideline “Q1A(R) Stability Testing of New Drug Substances and Products” (hereafter referred to as the parent guideline) to propose a retest period or shelf life in a registration application. This guideline describes when and how extrapolation can be considered when proposing a retest period for a drug substance or a shelf life for a drug product that extends beyond the period covered by “available data from the stability study under the long-term storage condition” (hereafter referred to as long-term data).
1.2 Background The guidance on the evaluation and statistical analysis of stability data provided in the parent guideline is brief in nature and limited in scope. The parent guideline states that regression analysis is an appropriate approach to analyzing quantitative stability data for retest period or shelf life estimation and recommends that a statistical test for batch poolability be performed using a level of significance of 0.25. However, the parent guideline includes few details and does not cover situations where multiple factors are involved in a full- or reduced-design study.
This guideline is an expansion of the guidance presented in the Evaluation sections of the parent guideline.
1.3 Scope of the Guideline This guideline addresses the evaluation of stability data that should be submitted in registration applications for new molecular entities and associated drug products.
The guideline provides recommendations on establishing retest periods and shelf lives for drug substances and drug products intended for storage at or below “room temperature”*. It covers stability studies using single- or multi-factor designs and full or reduced designs.
*Note: The term “room temperature” refers to the general customary environment and should not be inferred to be the storage statement for labeling.
ICH Q6A and Q6B should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of full- versus reduced-design studies.
Source: ICH, Pls check the follow
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