Standard Operating Procedure for Stability Study Sample Management
Purpose
The purpose of this SOP is to establish the procedures for the proper management of stability study samples in the pharmaceutical industry.
Scope
This SOP applies to all personnel involved in the collection, labeling, storage, and disposal of stability study samples conducted as part of the pharmaceutical product development process.
Responsibilities
- Quality Assurance: Responsible for overseeing and ensuring compliance with sample management procedures.
- Quality Control: Responsible for collecting, testing, and analyzing stability study samples.
- Sample Custodian: Responsible for the proper storage, labeling, and documentation of stability study samples.
Procedure
- Clearly label each stability study sample with relevant information, including batch number, date of collection, and storage conditions.
- Document the sampling process, including the quantity of samples collected, sampling location, and any deviations from the sampling plan.
- Transfer samples to the designated storage area immediately after collection, ensuring that storage conditions are maintained as per study requirements.
- Regularly monitor and record storage conditions, including temperature and humidity, for each stability chamber or storage unit.
- Perform periodic checks on the integrity of sample containers and packaging to prevent contamination or degradation.
- Maintain a detailed inventory of all stability study samples, including their current location, status, and any relevant testing schedule.
- Dispose of samples in accordance with the approved procedures and regulatory guidelines once the stability study is complete.
Abbreviations
No abbreviations are used in this SOP.
Documents
- Stability Study Sample Collection Log
- Stability Study Sample Inventory
- Stability Study Sample Disposal Record
Reference
No external references are used in this SOP.
SOP Version
Version 1.0