Initiating a Stability Study
Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide a step-by-step process for initiating a stability study, ensuring that all necessary preparations and documentation are completed to comply with regulatory requirements.
Scope
This SOP applies to all stability studies conducted on drug substances and drug products within the pharmaceutical company’s facilities.
Responsibilities
- Stability Manager: Approve and oversee the initiation of stability studies.
- Stability Technicians: Prepare samples, set up stability chambers, and ensure compliance with the stability protocol.
- Quality Assurance (QA) Team: Review and approve the stability protocol and ensure adherence to SOP.
Procedure
- Preparation of Stability Protocol:
- Develop a detailed stability protocol including objectives,
scope, sample details, storage conditions, and testing intervals.
Ensure the protocol is reviewed and approved by the Stability Manager and QA Team.
Sample Preparation:
Setting Up Stability Chambers:
Initiating the Study:
Documentation and Monitoring:
- Collect samples from the designated batch(es) according to the protocol.
- Label samples with identification codes, batch numbers, and storage conditions.
- Document the sample collection process and initial conditions.
- Place samples in the appropriate stability chambers set to the specified temperature and humidity conditions.
- Ensure stability chambers are calibrated and validated before use.
- Record the start date of the stability study in the stability protocol.
- Begin monitoring the storage conditions and ensure continuous recording of environmental parameters.
- Maintain detailed records of storage conditions, sample handling, and any deviations from the protocol.
- Review and verify data regularly to ensure compliance with the stability protocol.
Abbreviations Used
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Stability Protocol Template
- Sample Labeling Guidelines
- Stability Chamber Calibration Records
- Environmental Monitoring Logs
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]