Procedure for Creating Stability Protocols for Global Regulatory Markets
1) Purpose
The purpose of this SOP is to provide a standardized procedure for developing stability study protocols that comply with the regulatory requirements of multiple global markets to ensure successful product registration and commercialization.
2) Scope
This SOP applies to all drug products intended for submission to multiple global regulatory markets. It is relevant for personnel in regulatory affairs, research and development, and quality control departments.
3) Responsibilities
The responsibilities for developing stability protocols for global markets are as follows:
- Regulatory Affairs Team: To ensure that the protocol
meets the requirements of each target market’s regulatory guidelines.
R&D Team: To provide technical input into the design of the stability protocol.
Quality Control Team: To execute the stability testing as per the protocol and document results.
Stability Study Coordinator: To manage protocol development, testing schedules, and 
data collection.
4) Procedure
The detailed stepwise procedure for developing stability protocols for global markets is outlined below:
- Identify Target Markets:
- 4.1 Identify all target markets for product registration and commercialization.
- 4.2 Research the specific stability testing requirements for each target market (e.g., ICH, FDA, EMA, WHO).
- Design Stability Protocol:
- 4.3 Develop a stability protocol that incorporates the most stringent requirements of all target markets.
- 4.4 Define storage conditions, testing intervals, and critical quality attributes (CQAs) to be monitored.
- 4.5 Determine the types of stability studies required (e.g., long-term, accelerated, intermediate).
- Document Protocol:
- 4.6 Prepare a detailed stability study protocol document that includes all regulatory requirements.
- 4.7 Ensure the protocol is reviewed and approved by relevant stakeholders.
- Implementation and Compliance:
- 4.8 Implement the stability protocol across all sites conducting the stability studies.
- 4.9 Train all personnel involved in the stability studies on the requirements and procedures of the protocol.
- 4.10 Monitor compliance with the protocol throughout the study duration.
- Review and Update:
- 4.11 Regularly review the stability protocol to ensure it remains compliant with updated regulatory requirements.
- 4.12 Archive the approved protocol and report in a controlled document management system.
5) Abbreviations, if any
- ICH: International Council for Harmonisation
- FDA: Food and Drug Administration
- EMA: European Medicines Agency
- WHO: World Health Organization
6) Documents, if any
- Global Market Stability Protocol
- Regulatory Requirements Checklist
- Stability Testing Training Materials
7) Reference, if any
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- FDA Guidance for Industry: Stability Testing of Drug Substances and Products
- EMA Guideline on Stability Testing for Applications for Marketing Authorisation
8) SOP Version
Version 1.0