Scheduling and Environmental Conditions for US Validation/PM Stability Testing
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish the intervals and climatic conditions for conducting validation or post-marketing (PM) stability studies of drug substances and drug products intended for the US market. This ensures compliance with regulatory guidelines and generates reliable stability data critical for product validation and ongoing market approval.
Scope
This SOP applies to all validation and post-marketing stability studies conducted for drug substances and drug products intended for registration and approval in the US market.
Responsibilities
- Stability Manager: Approve the intervals and climatic conditions and ensure they meet regulatory guidelines
and company standards.
Stability Technicians: Implement the study intervals and climatic conditions as specified in this SOP and the stability protocol.
Quality Assurance (QA) Team: Review and approve intervals and conditions and ensure compliance with documentation standards.
Procedure
- Determine Study Intervals:
- Review regulatory guidelines (e.g., ICH Q1A(R2), FDA) to determine appropriate intervals for stability testing.
- Establish the following testing intervals:
- Accelerated Testing: 0, 1, 3, and 6 months
- Long-term Testing: 0, 3, 6, 9, 12, 18, and 24 months, then annually thereafter until the end of the proposed shelf life
- Intermediate Testing (if applicable): 0, 3, 6, 9, and 12 months
- Review regulatory guidelines (e.g., ICH Q1A(R2), FDA) to
- Determine Climatic Conditions:
- Set up storage conditions based on the climatic zones relevant to the US market:
- Long-term Storage: 25°C ± 2°C / 60% RH ± 5% RH
- Accelerated Storage: 40°C ± 2°C / 75% RH ± 5% RH
- Intermediate Storage (if needed): 30°C ± 2°C / 65% RH ± 5% RH
- Calibrate and validate storage units to ensure consistent performance.
- Install monitoring devices (e.g., temperature and humidity sensors) in each unit.
- Set up storage conditions based on the climatic zones relevant to the US market:
- Label and Organize Samples:
- Assign each sample a unique identifier.
- Label samples with storage conditions, study identifiers, and time points.
- Organize samples by study, batch, and time point within the storage units.
- Monitor Storage Conditions:
- Regularly monitor and record storage conditions (e.g., temperature, humidity).
- Set up alarms and alerts for deviations from specified conditions.
- Document any deviations and corrective actions taken.
- Document Study Intervals and Conditions:
- Record all intervals and conditions in the stability protocol and associated logs.
- Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
- Perform Regular Audits:
- Conduct regular audits of storage conditions to ensure ongoing compliance.
- Document audit findings and take corrective actions if necessary.
- Review and Approval:
- Submit the intervals and conditions to the Stability Manager and QA Team for review and approval.
- Make any necessary adjustments based on feedback and finalize the study intervals and conditions.
- Communication:
- Communicate the finalized intervals and conditions to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
Abbreviations Used
- QA: Quality Assurance
- RH: Relative Humidity
- SOP: Standard Operating Procedure
- ICH: International Council for Harmonisation
Documents
- Stability Protocol
- Storage Unit Calibration and Validation Records
- Storage Condition Monitoring Logs
- Audit Reports
- Regulatory Guidelines
References
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products
- FDA Guidance for Industry: Stability Testing of Drug Substances and Drug Products
SOP Version
Version 1.0 – Effective Date: [Insert Date]