718 Industrial Pharmacy: A Comprehensive Approach Matrixing is the design of a stability schedule such that a selected subset of the total number of possible samples for all factor combinations would be tested at a specified time point. At a subsequent time point, another subset of samples for all factor combinations would be tested. The design assumes that the stability of each subset of samples tested represents the stability of all samples at a given time point. Evaluation of Stability Data (Q1E) This guideline recommends on how to use the stability data generated during the stability testing as per ICH guidelines of new drug substances and the products. That is how to evaluate the stability data that should be submitted in registration applications for new molecular entities and associated drug products. The guideline also recommends 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. The purpose of a stability study is to establish a retest period or shelf life and label storage instructions. For which testing of a jum of three batches of the drug substance or product is required. The shelf life and label storage instructions should be applicable to all future batches manufactured and packaged under similar circumstances. The degree of variability of individual batches determines whether future production batch will remain within acceptance criteria throughout its retest period or shelf life. Thus, a systematic approach should be adopted in the presentation and evaluation of the stability data. The stability information should include, the data on physical, chemical, biological, and microbiological tests, including those related to particular attributes of the dosage form (for example, dissolution rate for solid oral dosage forms), Stability Data Package for Registration Applications in Climatic Zones Ill and IV, (Q1F) This guideline is an annex to the parent guideline, “Q1A(R) Stability Testing of New Drug Substances and Products” and recommends the long-term storage condition for stability testing of a new drug substance or drug product for registration application in territories in Climatic Zones til and IV. This guideline should be used in combination with the parent guideline. The recommendations in the parent guideline and annexes should be followed unless specific alternatives are described within this guideline. The following sections of the parent guideline can be considered common to any territory in the world and are not reproduced here: © Stress testing * Selection of batches Ul O <