Guidelines for Bracketing and Matrixing Studies as per ICH Q1D
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for conducting bracketing and matrixing studies of drug substances and drug products in accordance with the ICH Q1D guidelines. These studies are designed to reduce the number of stability tests and samples while ensuring the stability of the product under different conditions.
2) Scope
This SOP applies to all personnel involved in the design, execution, and documentation of bracketing and matrixing studies for drug substances and drug products intended for
3) Responsibilities
Stability Testing Team: Responsible for conducting bracketing and matrixing studies, collecting data, and documenting results as per ICH Q1D guidelines.
Quality Assurance (QA) Team: Responsible for reviewing and approving study protocols and reports, ensuring compliance with regulatory requirements.
Regulatory 
4) Procedure
4.1 Preparation for Bracketing and Matrixing Studies
4.1.1 Obtain and review the latest version of the ICH Q1D guidelines on bracketing and matrixing studies.
4.1.2 Identify the drug substance or product to be tested and determine the appropriate study design (bracketing or matrixing) based on the product’s characteristics and intended market.
4.1.3 Develop a study protocol that includes the study design, testing schedule, storage conditions, and testing parameters as per ICH Q1D guidelines.
4.2 Selection of Batches and Samples
4.2.1 Select representative batches of the drug product, considering the range of strengths, packaging configurations, and production variations.
4.2.2 Prepare sufficient samples to cover the study duration, considering the number of time points and tests to be conducted under the bracketing or matrixing design.
4.3 Conducting the Bracketing and Matrixing Studies
4.3.1 Store samples under the defined conditions, ensuring appropriate bracketing (testing extremes of certain design factors) or matrixing (testing a subset of samples).
4.3.2 Conduct stability-indicating tests at each specified time point according to the approved protocol.
4.3.3 Record all results in stability data sheets, ensuring accuracy and traceability.
4.4 Data Analysis and Documentation
4.4.1 Review the stability data to identify any trends, deviations, or out-of-specification (OOS) results.
4.4.2 Investigate any OOS results, document findings, and implement corrective actions as necessary.
4.4.3 Compile a stability report that includes a summary of the study design, results, conclusions, and recommendations for the product’s shelf life and storage conditions.
5) Abbreviations, if any
ICH: International Council for Harmonisation
QA: Quality Assurance
OOS: Out-of-Specification
6) Documents, if any
Study protocol, stability data sheets, testing records, study report, submission package to regulatory authorities.
7) Reference, if any
ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products.
8) SOP Version
Version 1.0