Guidelines for Developing a Stability Protocol as per ICH Q1A(R2)
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for preparing a stability protocol for drug substances and drug products in compliance with the ICH Q1A(R2) guidelines. This SOP ensures that the stability protocol is comprehensive, clear, and in line with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in the preparation and review of stability protocols for drug substances and drug products intended for global markets.
3) Responsibilities
Stability Testing Team: Responsible for drafting the stability
Quality Assurance (QA) Team: Responsible for reviewing and approving the stability protocol.
Regulatory Affairs Team: Responsible for ensuring that the protocol meets regulatory expectations and is aligned with submission requirements.
4) Procedure
4.1 Initial Preparation
4.1.1 Obtain and review the latest version
4.1.2 Identify the drug substance or product and determine the type of stability study required (e.g., long-term, accelerated, or intermediate).
4.2 Components of the Stability Protocol
4.2.1 Include the following sections in the stability protocol:
- Objective and scope of the study
- Details of the drug substance or product, including batch number and manufacturing date
- Storage conditions and time points
- Tests to be conducted, including methods and acceptance criteria
- Responsibilities of the personnel involved
- Schedule for sampling, testing, and reporting
4.3 Approval and Finalization
4.3.1 Submit the draft protocol to the QA Team for review and approval.
4.3.2 Address any discrepancies or required changes identified by the QA Team and finalize the protocol for implementation.
5) Abbreviations, if any
ICH: International Council for Harmonisation
QA: Quality Assurance
6) Documents, if any
Draft stability protocol, approved stability protocol.
7) Reference, if any
ICH Q1A(R2): Stability Testing of New Drug Substances and Products.
8) SOP Version
Version 1.0