gel batches under processing, prior to filling and packaging.

3. Responsibilities

• Production Chemist: Responsible for timely sampling and submission of samples to the QC lab.
• Quality Control Analyst: To perform analysis of submitted semi-finished gel samples as per approved specifications.
• Quality Assurance: To verify records and authorize further manufacturing steps based on test results.

4. Accountability

The Head – Manufacturing shall ensure compliance with this SOP and coordinate with QA and QC for timely release of semi-finished material.

5. Procedure

5.1 Preparation for Sampling

1. Ensure the homogenization and mixing of the gel batch is complete.
2. Verify cleanliness and calibration status of sampling tools.
3. Wear sterile gloves, head cap, and gown before entering the sampling area.

5.2 Sampling Method

1. Draw representative samples from top, middle, and bottom layers of the manufacturing vessel to ensure homogeneity.
2. Use a sanitized stainless steel spatula or dipper under LAF conditions.
3. Transfer samples into clean, labeled, inert containers with batch number, stage, date, and signature.
4. Ensure containers are closed tightly to avoid contamination or evaporation.

5.3 Sample Quantity

• Minimum of 100 g or as defined in the product specification sheet.
• Retain one portion as reference sample and send the other to QC for analysis.

5.4 Testing Parameters

The following tests must be performed on semi-finished gel samples:

• Appearance: Check for color, consistency, absence of lumps or phase separation.
• pH: Measure using calibrated pH meter.
• Viscosity: Using Brookfield viscometer at defined RPM and temperature.
• Homogeneity: Evaluate visually and by uniformity of content if applicable.
• Microbial Limit Test: As per pharmacopeial requirement if defined for stage control.

5.5 Documentation

1. Record sampling details in the Semi-Finished Gel Sampling Log – Annexure-1.
2. Record test results in the QC In-Process Testing Report – Annexure-2.
3. QC to return results to manufacturing within specified TAT (typically within 4–6 hours).
4. Approval or rejection decision to be documented by QA in the BMR.

5.6 Handling Out of Specification (OOS)

1. If results fall outside specifications, immediately notify QA and halt further processing.
2. Initiate OOS investigation as per SOP and document corrective/preventive actions.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• LAF: Laminar Air Flow
• TAT: Turnaround Time

7. Documents

1. Semi-Finished Gel Sampling Log – Annexure-1
2. QC In-Process Testing Report – Annexure-2
3. Batch Manufacturing Record (BMR)

8. References

• WHO TRS – GMP Guidelines
• Schedule M (India) for Pharmaceutical Production
• Internal SOPs on QC Testing and OOS Handling

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: Semi-Finished Gel Sampling Log

Record date, time, sampler name, batch number, sampling point, and remarks.

Annexure-2: QC In-Process Testing Report

Includes specification limits, observed values, analyst initials, and disposition status.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial version issued	Process documentation requirement	QA Head
02/06/2025	2.0	Expanded to include microbial testing provision	Regulatory update compliance	QA Head