SOP for Sampling During Manufacturing – V 2.0

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