Standard Operating Procedure for In-process Sampling During Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/061/2025 |
| Supersedes | SOP/ELX/061/2022 |
| 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 systematic and representative in-process sampling during the manufacturing of elixirs to monitor quality attributes such as pH, appearance, assay, homogeneity, and microbial control.
2. Scope
This SOP is applicable to all batches of elixir formulations manufactured in the Elixir Department where in-process sampling is required before bulk filtration or packing.
3. Responsibilities
- Production Operator:
- Collect in-process samples as per instructions and aseptic practices.
- Label and transfer samples to QA/QC for analysis.
- QA Officer:
- Verify sampling procedure and review in-process control results.
- Authorize continuation or halt of processing based on results.
- QC Analyst:
- Perform pH, assay, and microbial tests as applicable.
- Enter results in the In-process Test Report and communicate to QA.
4. Accountability
The QA Manager is accountable for ensuring sampling is representative and results are reviewed before next critical processing step.
5. Procedure
5.1 Sampling Plan
- Refer to the BMR or In-Process Control Plan for specific sampling time points.
- Typical sampling stages include:
- After mixing/homogenization
- Post pH adjustment
- Before bulk filtration
5.2 Sampling Method
- Use clean and sterilized stainless steel or HDPE ladles and containers for sample collection.
- Collect samples from three points:
- Top
- Middle
- Bottom
- Mix all three portions in a sterile container and label as “Composite Sample.”
- Label the container with:
- Product Name
- Batch Number
- Date & Time of Sampling
- Sample Point
- Collected By
5.3 Tests Performed
- QC shall perform:
- Appearance
- pH
- Assay (as per specification)
- Microbial Limit (if required)
5.4 Documentation
- Record sample collection details in the In-process Sampling Log (Annexure-1).
- Attach In-process Test Report (Annexure-2) to BMR after QA review.
5.5 Precautions
- Ensure equipment used for sampling is sanitized.
- Do not open the tank for extended time to avoid microbial exposure.
- Do not return excess sample to the batch.
6. Abbreviations
- SOP: Standard Operating Procedure
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
- QC: Quality Control
- CFU: Colony Forming Unit
7. Documents
- In-process Sampling Log (Annexure-1)
- In-process Test Report (Annexure-2)
- Sampling Equipment Cleaning Log (Annexure-3)
8. References
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
- WHO GMP Guidelines – Section 7: Production
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: In-process Sampling Log
| Date | Batch No. | Sample Point | Collected By | Verified By |
|---|---|---|---|---|
| 11/04/2025 | ELX-1007 | Composite (T/M/B) | Rajesh Kumar | Sunita Reddy |
Annexure-2: In-process Test Report
| Parameter | Specification | Result | Status |
|---|---|---|---|
| Appearance | Clear, colorless | Clear | Pass |
| pH | 4.5–5.5 | 4.8 | Pass |
| Assay | 95%–105% | 98.6% | Pass |
Annexure-3: Sampling Equipment Cleaning Log
| Date | Equipment ID | Cleaned By | Verified By | Status |
|---|---|---|---|---|
| 11/04/2025 | SPL-01 | Ajay Desai | Manju Sharma | Cleaned |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Issue | New SOP | QA Head |
| 11/04/2025 | 2.0 | Added Composite Sampling and Annexure Updates | Compliance with WHO GMP | QA Head |