Standard Operating Procedure for Sampling During Elixir Manufacturing
| Department | Elixir Department |
|---|---|
| SOP No. | SOP/ELX/191/2025 |
| Supersedes | SOP/ELX/191/2022 |
| Page No. | Page 1 of 9 |
| Issue Date | 11/04/2025 |
| Effective Date | 15/04/2025 |
| Review Date | 11/04/2026 |
1. Purpose
To establish a standardized and compliant procedure for in-process sampling during the manufacturing of elixirs in order to monitor and ensure quality at critical processing stages.
2. Scope
This SOP is applicable to all sampling activities performed during the manufacturing process of elixirs including, but not limited to, sampling for pH, specific gravity, appearance, alcohol content, microbial limits, and in-process uniformity.
3. Responsibilities
- Production Operator:
- Draw samples as per sampling plan and label them appropriately.
- QA Officer:
- Monitor sampling activities and ensure GMP compliance.
- QC Analyst:
- Test the samples and report results to QA/Production.
4. Accountability
The Production Head is accountable for ensuring sampling at defined stages. QA is accountable for sampling plan implementation and QC is responsible for analysis and reporting.
5. Procedure
5.1 Sampling Plan
- Follow the approved Batch Manufacturing Record (BMR) or
Sampling Plan issued by QA for each product.
Samples to be taken at the following stages:
- Post-dissolution of active ingredient
- Post-addition of sweeteners and alcohol
- Pre-filtration
- Post-filtration (bulk sample)
5.2 Sampling Procedure
- Use cleaned and dried sampling containers labelled with:
- Product Name
- Batch No.
- Sampling Point
- Date & Time
- Sampled By
- Wear sterile gloves and use sanitized sampling accessories (e.g., ladles, pumps).
- Ensure uniform mixing in the tank before drawing samples.
- Collect at least 3 individual samples for QC testing unless otherwise specified.
- Close the sampling point and clean the area after collection.
5.3 Sample Handling and Transfer
- Transfer the labeled sample to the QC department along with the sampling requisition slip.
- Ensure samples are handled without spillage or exposure to heat/light.
- QC to acknowledge sample receipt and record in Sample Receipt Logbook.
5.4 Testing and Documentation
- QC performs analysis as per in-process specification:
- pH, Specific Gravity
- Alcohol Content (if applicable)
- Appearance, Color, Odor
- Microbial Limit Tests
- Record sampling details in the In-Process Sampling Logbook (Annexure-1).
- QC shall report any OOS results immediately to QA and Production.
5.5 Precautions
- Do not touch the inside of sampling containers or accessories.
- Ensure sampling does not interfere with product sterility (if applicable).
- Discard any damaged or improperly labeled samples.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- QC: Quality Control
- BMR: Batch Manufacturing Record
- OOS: Out of Specification
7. Documents
- In-Process Sampling Logbook (Annexure-1)
- Sample Requisition Slip
- Sample Receipt Logbook
8. References
- 21 CFR Part 211.110 – Sampling and Testing of In-Process Materials
- WHO TRS 986 – GMP for Pharmaceutical Products
- ICH Q8 – Pharmaceutical Development
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 Logbook
| Date | Product Name | Batch No. | Sampling Point | Sampled By | QC Receipt Time | Remarks |
|---|---|---|---|---|---|---|
| 11/04/2025 | Herbal Elixir A | ELX-0425-010 | Post Alcohol Addition | Rajesh Kumar | 11:45 AM | Transferred to QC |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Release | New SOP | QA Head |
| 11/04/2025 | 2.0 | Sampling points and checklist revised | Audit Compliance | QA Head |