Standard Operating Procedure for Sampling for Stability from Manufacturing Tank
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/101/2025 |
| Supersedes | SOP/ELX/101/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To define the procedure for collecting representative samples from the manufacturing tank for the purpose of conducting stability studies as per regulatory and internal quality requirements.
2. Scope
This SOP applies to the collection, labeling, and handling of stability samples from the final bulk elixir prior to bottling or packaging in the Elixir Department.
3. Responsibilities
- Production Operator:
- Collect the sample under supervision using sanitized sampling tools.
- QA Officer:
- Verify sampling process and ensure proper labeling, documentation, and transfer to QC or stability chamber.
- QC Analyst:
- Perform initial testing and arrange stability storage under defined conditions.
4. Accountability
The Head of Quality Assurance is accountable for ensuring proper sampling, traceability, and documentation of stability samples as per ICH and GMP guidelines.
5. Procedure
5.1 Preparation Before Sampling
- Confirm that the
batch is approved for stability sampling by QC.
Ensure that the manufacturing tank is labeled “Ready for Sampling.”
Prepare sampling containers labeled with:
Use sanitized stainless steel or glass containers with tight closures for sample collection.
- Product Name
- Batch Number
- Sampling Date
- Stability Time Point (Initial, 1M, 3M, etc.)
- Storage Conditions (e.g., 25°C/60% RH)
5.2 Sampling Procedure
- Open the manhole under controlled conditions if sampling is done manually; alternatively, use a sampling port if available.
- Ensure that the sampler (ladle or valve) is disinfected and rinsed with a small quantity of the product before collecting the final sample.
- Collect representative samples from different depths (top, middle, and bottom) if required by protocol.
- Transfer the sample to pre-labeled containers and seal securely.
- Record sampling details in the Stability Sampling Log (Annexure-1).
5.3 Post-Sampling Activities
- Deliver the samples to the QC laboratory or stability storage area immediately.
- Ensure that all unused sample material is disposed of as per waste management SOPs.
- Clean and disinfect the sampling port or equipment after use.
5.4 Documentation
- Record sampling date, batch number, sampler name, container ID, and destination.
- Attach a copy of the Stability Protocol if applicable to the BMR.
- Ensure that all entries are verified and signed by QA and Production Supervisor.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
- RH: Relative Humidity
7. Documents
- Stability Sampling Log (Annexure-1)
- Stability Protocol (if applicable)
- Batch Manufacturing Record (BMR)
8. References
- ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
- WHO TRS 1010 – Guidelines on Stability Testing
- 21 CFR Part 211.166 – Stability Testing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Stability Sampling Log
| Date | Batch No. | Sampled By | Container ID | Volume | Stability Time Point | Storage Condition | QA Verified |
|---|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1040 | Rajesh Kumar | SS-01 | 250 mL | 0 Month | 25°C / 60% RH | Sunita Reddy |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Updated sampling instructions and documentation process | GMP Alignment | QA Head |