Gel Manufacturing: SOP for In-process Sampling and Testing during Gel Manufacturing – V 2.0

Auditor

7 months ago

Standard Operating Procedure for In-process Sampling and Testing in Gel Manufacturing

Department	Gel Manufacturing
SOP No.	SOP/GM/164/2025
Supersedes	SOP/GM/164/2022
Page No.	Page 1 of 11
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To establish a standard procedure for in-process sampling and testing during gel manufacturing for monitoring product quality and ensuring compliance with specified in-process control parameters.

2. Scope

This SOP applies to all gel formulations manufactured at this facility. It covers procedures for collecting in-process samples, testing them for defined parameters, and documenting results for evaluation during batch release.

3. Responsibilities

Production Operator: Responsible for informing QA and collecting samples as per defined intervals.
Quality Assurance (QA): Monitors sampling activities, ensures compliance, and approves sample collection timing and methods.
Quality

Control (QC): Conducts analytical testing on in-process samples and reports results to production and QA.

4. Accountability

Manager – Quality Assurance and Head – Manufacturing are accountable for the implementation and adherence to this SOP.

5. Procedure

5.1 Sampling Plan and Time Points

Refer to the batch manufacturing record (BMR) for sampling intervals and quantity of each sample.
Typical in-process samples include those taken after dispersion, after homogenization, and before final packing.
Label each sample with the product name, batch number, stage, time of collection, and sampled by.

5.2 Sample Handling and Transfer

Use clean, dry, and inert containers for sample collection.
Avoid contamination by using sanitized spatulas or sampling devices.
Transfer samples immediately to QC lab with appropriate documentation.

5.3 In-process Parameters for Gel

Appearance: Uniformity, color, absence of lumps or air bubbles.
pH: Measured at room temperature using calibrated pH meter.
Viscosity: Tested using Brookfield viscometer as per standard method.
Homogeneity: Visual and microscopic examination if needed.
Weight per mL: Checked to ensure correct volume-fill.

5.4 Testing and Reporting

QC to test each in-process sample within the defined time frame.
Record results on In-process Quality Control (IPQC) form.
Highlight any deviations or out-of-specification results and inform QA and production immediately.

5.5 Trending and Investigation

QA to review in-process data for trends or variations across batches.
Initiate investigation in case of recurring deviations or parameter drift.
Corrective and preventive actions (CAPA) to be documented if applicable.

6. Abbreviations

IPQC: In-Process Quality Control
BMR: Batch Manufacturing Record
QA: Quality Assurance
QC: Quality Control

7. Documents

In-process Sampling Log – Annexure-1
IPQC Result Sheet – Annexure-2
Sample Transfer Note – Annexure-3

8. References

WHO TRS 986 Annex 2 – GMP Guidelines for Pharmaceuticals
ICH Q8 – Pharmaceutical Development
Internal Quality Manual

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: In-process Sampling Log

Product
Batch No.
Stage
Sampling Time
Collected By
Container No.
Remarks

Annexure-2: IPQC Result Sheet

Parameter	Specification	Result	Status (Pass/Fail)	Analyst
Appearance
pH
Viscosity

Annexure-3: Sample Transfer Note

Date
Product
Batch No.
Sampling Stage
Sample Transferred To	QC Department
Remarks
Signature (Production)

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
24/05/2022	1.0	Initial version	New SOP	QA Head
09/06/2025	2.0	Revised to include annexures and trending procedure	GMP compliance	QA Head