Preparing a Schedule for Withdrawal of Stability Samples Completing Storage Period
Purpose
The purpose of this SOP is to outline the procedure for preparing a schedule for the withdrawal of stability samples that have completed their designated storage period.
Scope
This SOP applies to all stability studies conducted within the pharmaceutical company where samples are withdrawn at specific intervals for testing.
Responsibilities
- Stability Coordinator: Responsible for creating and maintaining the withdrawal schedule.
- Quality Control (QC) Department: Responsible for withdrawing the samples as per the schedule and performing the necessary tests.
- Quality Assurance (QA) Department: Responsible for reviewing and approving the withdrawal schedule and ensuring compliance with the
SOP.
Procedure
1. Review Stability Study Protocol
- Obtain the stability study protocol for each product under stability testing.
- Identify the specified storage conditions and test intervals for each product.
2. Prepare Withdrawal Schedule
- Create a master schedule in a tabular format that includes:
- Product Name
- Batch Number
- Storage Condition
- Start Date of Stability Study
- Scheduled Withdrawal Dates (e.g., T0, 1 month, 3 months, 6 months, etc.)
- Ensure that the schedule covers all required intervals as per the stability study protocol.
- Use software or a spreadsheet to track and update the schedule as needed.
3. Schedule Review and Approval
- Submit the prepared schedule to the QA department for review and approval.
- Ensure that any changes or updates to the schedule are communicated to all relevant departments.
4. Sample Withdrawal
- QC department withdraws samples on the scheduled dates.
- Ensure samples are labeled correctly and stored under appropriate conditions until testing.
5. Record Keeping
- Document each withdrawal in the stability study logbook.
- Record the date, time, and initials of the person performing the withdrawal.
- Note any deviations or issues encountered during the withdrawal process.
Abbreviations
- QC: Quality Control
- QA: Quality Assurance
Documents
- Stability Study Protocol
- Stability Study Logbook
- Withdrawal Schedule
References
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- Company SOP on Stability Testing
SOP Version
Version: 1.0
Effective Date: [Insert Date]