Standard Operating Procedure for Sampling of Raw Materials in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/136/2025 |
| Supersedes | SOP/GM/136/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To define the procedure for sampling raw materials used in the manufacturing of gel formulations to ensure proper identification, traceability, and conformance with established quality specifications.
2. Scope
This SOP applies to the sampling of all active pharmaceutical ingredients (APIs), excipients, preservatives, and other
raw materials used in gel manufacturing.
3. Responsibilities
- Warehouse Executive: Prepares materials for sampling and maintains records.
- QC Analyst: Performs sampling using appropriate technique and labeling.
- QA Officer: Verifies adherence to SOP and GMP during sampling activity.
4. Accountability
Manager – Quality Control
5. Procedure
5.1 Sampling Environment
- Ensure the sampling is conducted in a controlled area designated for raw material sampling.
- Clean and sanitize the sampling booth, tools, and surfaces before and after sampling.
5.2 Sampling Tools and Containers
- Use only sanitized stainless steel or single-use sampling tools.
- Ensure containers for samples are clean, labeled, and appropriate for the material type (e.g., light-resistant, moisture-proof).
5.3 Sampling Method
- Perform sampling based on the sampling plan defined in SOP/QA/012/2025 and per ICH Q7 guidelines.
- For each consignment, sample from top, middle, and bottom of at least 10% of containers (minimum of one) or as per risk-based sampling strategy.
- Ensure composite samples are created where applicable and placed in primary sample containers.
5.4 Sample Labeling
- Each sample container must be labeled with the following information:
- Material Name and Code
- Batch Number
- Supplier Name
- Date of Sampling
- Sampled By
5.5 Sample Quarantine and Storage
- After sampling, store the material in a designated quarantine area until QC analysis is complete.
- Samples shall be submitted to QC within 2 hours of sampling or as per material characteristics.
5.6 Deviation Handling
- In case of any deviation (e.g., damaged containers, contamination, sampling outside specifications), initiate a deviation report and inform QA immediately.
6. Abbreviations
- API: Active Pharmaceutical Ingredient
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
7. Documents
- Raw Material Sampling Log – Annexure-1
- Sample Label Template – Annexure-2
- Environmental Cleaning Checklist – Annexure-3
8. References
- ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- WHO TRS 1010 Annex 2
- Schedule M: GMP Guidelines for Pharmaceuticals
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Raw Material Sampling Log
| Material Name | |
|---|---|
| Material Code | |
| Batch No. | |
| No. of Containers | |
| No. of Containers Sampled | |
| Sampled By | |
| Date |
Annexure-2: Sample Label Template
| Label Field | Details |
|---|---|
| Material Name | |
| Material Code | |
| Batch No. | |
| Date of Sampling | |
| Sampled By |
Annexure-3: Environmental Cleaning Checklist
| Area | Cleaned (Yes/No) | Sanitized (Yes/No) | Checked By | Date |
|---|---|---|---|---|
| Sampling Booth | ||||
| Sampling Tools |
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 10/02/2022 | 1.0 | Initial issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Updated procedure to align with ICH Q7 | Annual Review | QA Head |