Standard Operating Procedure for Sampling from Storage Tank in Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/081/2025 |
| Supersedes | SOP/ELX/081/2022 |
| 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 storage tank containing bulk elixir solution for the purpose of quality control testing, ensuring uniformity, compliance, and traceability.
2. Scope
This SOP applies to the collection of in-process, final bulk, and stability samples from storage tanks in the Elixir Department before filtration or filling.
3. Responsibilities
- Production Operator:
- Clean sampling point, perform sample withdrawal, and label samples correctly.
- QC Chemist:
- Receive samples, perform testing, and record results.
- QA Officer:
- Verify sample label details and ensure documentation is accurate and complete.
4. Accountability
The Head of Production is accountable for ensuring samples are taken in a GMP-compliant manner and reflect true batch quality.
5. Procedure
5.1 Pre-Sampling Preparation
- Verify that the storage tank is labeled with product name, batch number, and volume.
- Confirm that
the sampling point is accessible, sanitized, and within expiry of cleaning validation.
Assemble sterile sampling containers, labels, gloves, and a sanitized tray.
5.2 Sampling Technique
- Wipe the sampling valve and adjacent area with sterile lint-free cloth soaked in 70% IPA.
- Open the valve and discard a small initial quantity (approx. 50 mL) to flush the line.
- Collect samples as per requirement:
- For QC testing: 3 containers (Top, Middle, Bottom)
- For stability or retain: 1 container (composite sample)
- Close the sampling valve securely after collection.
5.3 Labeling and Dispatch
- Label each sample container with:
- Product Name
- Batch Number
- Sample Type (Top/Middle/Bottom/Composite)
- Sampling Date and Time
- Sampled By
- Send samples to the QC laboratory along with the Sample Intimation Slip (Annexure-1).
5.4 Documentation
- Record sampling activity in the Sampling Logbook (Annexure-2).
- Attach a copy of the log to the BMR and retain original with QA.
6. Abbreviations
- SOP: Standard Operating Procedure
- QC: Quality Control
- QA: Quality Assurance
- BMR: Batch Manufacturing Record
- IPA: Isopropyl Alcohol
7. Documents
- Sample Intimation Slip (Annexure-1)
- Sampling Logbook (Annexure-2)
- Batch Manufacturing Record (BMR)
8. References
- 21 CFR Part 211.110 – Sampling and Testing of In-Process Materials
- WHO TRS 1010 – GMP for Pharmaceutical Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sample Intimation Slip
| Product Name | Batch No. | Sample Type | Quantity | Sampling Date | Sampled By |
|---|---|---|---|---|---|
| Paracetamol Elixir | ELX-1020 | Composite | 100 mL | 11/04/2025 | Rajesh Kumar |
Annexure-2: Sampling Logbook
| Date | Batch No. | Sample Type | Volume | Time | Operator | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | ELX-1020 | Top/Middle/Bottom | 3 x 100 mL | 11:00 AM | Rajesh Kumar | Clean sampling observed |
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 | Added Sampling Types and Intimation Slip | QA Recommendation | QA Head |