Sample Labeling Procedure for Stability Testing
Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a standardized method for labeling stability study samples to ensure accurate identification, traceability, and compliance with regulatory requirements.
Scope
This SOP applies to all stability study samples of drug substances and drug products within the pharmaceutical company’s facilities.
Responsibilities
- Stability Manager: Approve the labeling process and ensure it meets regulatory guidelines and company standards.
- Stability Technicians: Implement the labeling process as specified in this SOP and the stability protocol.
- Quality Assurance (QA) Team: Review and approve labeling procedures and ensure compliance with documentation standards.
Procedure
- Label Content:
- Each label must include the following
information:
Label Preparation:
Labeling Process:
Documentation:
Quality Control:
Review and Approval:
Communication:
- Sample ID or Code
- Batch Number
- Storage Condition (e.g., 25°C/60% RH)
- Sampling Time Point (e.g., 0, 3, 6, 9 months)
- Product Name and Strength
- Expiration Date
- Additional Information as required (e.g., Test Type)
- Use a standardized template for all sample labels.
- Print labels using a high-quality, legible font.
- Ensure labels are waterproof and resistant to fading.
- Verify that each sample container is clean and dry before labeling.
- Affix the label to the sample container in a manner that ensures it remains intact throughout the stability study.
- Double-check label accuracy against the stability protocol and batch records.
- Record the label information in the stability protocol and associated logs.
- Ensure all documentation is reviewed and approved by the Stability Manager and QA Team.
- Perform a quality control check to verify the accuracy and completeness of the labels.
- Document any discrepancies and take corrective actions as necessary.
- Submit the labeling process and sample labels to the Stability Manager and QA Team for review and approval.
- Make any necessary adjustments based on feedback and finalize the labeling process.
- Communicate the finalized labeling process to all relevant stakeholders, including Stability Technicians, QA Team, and project managers.
Abbreviations Used
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- RH: Relative Humidity
Documents
- Stability Protocol
- Labeling Template
- Batch Production Records
- Sample Collection and Labeling Records
- 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]