Procedure for Sampling During Manufacturing
| Department | Production/Quality Assurance (QA)/Quality Control (QC) |
|---|---|
| SOP No. | SOP/Ointment/028 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for sampling ointment batches during manufacturing. Proper sampling ensures that the product meets predefined quality parameters, including uniformity, consistency, and compliance with GMP regulations.
2. Scope
This SOP applies to the Quality Control (QC) and Quality Assurance (QA) departments responsible for in-process sampling during the manufacturing of ointments.
3. Responsibilities
- Production Supervisor: Ensures that the batch is prepared for sampling at designated stages.
- QC Analyst: Collects, analyzes, and documents sample test results.
- QA Personnel: Monitors compliance with GMP and verifies sample integrity.
- R&D Scientist: Assists in method development for sampling if required.
4. Accountability
The QA and QC Managers are accountable for ensuring that sampling procedures are conducted as per GMP and documented properly.
5. Procedure
5.1 Pre-Sampling Preparations
- Ensure that all sampling tools (spatulas, sample bottles, sterile gloves) are sanitized.
- Verify batch details from the Batch Manufacturing Record (BMR).
- Label all sample containers with batch number, date, and sampling stage.
- Ensure that personnel involved in sampling wear appropriate PPE.
5.2 Sampling Stages
- Raw Material Sampling: Before ingredient addition to confirm purity.
- In-Process
Sampling: During mixing, homogenization, and cooling stages.
Final Bulk Sampling: Before transferring ointment to filling machines.
5.3 Sampling Techniques
- Use a random sampling method to ensure representative analysis.
- For semi-solid ointments, collect samples using a sterilized spatula.
- Ensure that sampling points are selected from multiple locations (top, middle, bottom).
- Store samples in sealed, labeled containers to avoid contamination.
5.4 In-Process Quality Control Tests
- Perform the following tests on collected samples:
- pH Measurement: Ensures product acidity or alkalinity is within range.
- Viscosity Testing: Confirms proper flow characteristics.
- Uniformity Analysis: Checks for active ingredient distribution.
- Microbial Testing: Ensures absence of contamination.
- Document all results in the Sampling Log.
5.5 Approval and Finalization
- QA personnel must review test results before approving further processing.
- Retain a portion of the sample for stability studies if required.
- Dispose of any rejected batch portions following GMP waste disposal guidelines.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- BMR – Batch Manufacturing Record
7. Documents
- Sampling Log (Annexure-1)
- In-Process Test Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7: Good Manufacturing Practice Guide for APIs
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sampling Log
| Date | Batch Number | Sampling Stage | Sample Type | Collected By | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | Mixing | Viscosity Sample | John Doe | QA Officer |
| 02/02/2025 | SOP/Ointment/002 | Cooling | pH Sample | Jane Smith | QA Officer |
Annexure-2: In-Process Test Report
| Date | Batch Number | Test Parameter | Specification | Result | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | SOP/Ointment/001 | pH | 5.5-7.0 | 6.2 | Pass |
| 02/02/2025 | SOP/Ointment/002 | Microbial Test | Absent | Absent | Pass |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |