Standard Operating Procedure for Validation of Gelatin Solution Preparation Processes

Department	Capsule Manufacturing
SOP No.	SOP/CM/152/2025
Supersedes	SOP/CM/152/2022
Page No.	Page 1 of 7
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to define the process for validating gelatin solution preparation processes used in capsule manufacturing. The gelatin solution serves as the base for capsule shells, and its consistency and quality are critical to the final product’s integrity. This SOP ensures that the gelatin preparation process is consistently reproducible and meets all necessary specifications.

2. Scope

This SOP applies to the preparation, validation, and testing of gelatin solutions used in capsule manufacturing. The validation process ensures that the gelatin solution is prepared under controlled conditions that produce the desired quality attributes consistently. This SOP covers the entire process, from ingredient selection to the final gelatin solution used for encapsulation.

3. Responsibilities

• Production Operators: Responsible for preparing the gelatin solution according to the specified procedures and monitoring key parameters during the preparation process.
• Quality Control (QC) Team: Performs testing on the gelatin solution to ensure it meets quality specifications, such as viscosity, pH, and clarity. Also verifies that the validation process is followed correctly.
• Quality Assurance (QA) Team: Reviews the gelatin solution validation plan, approves test methods, and ensures the validation process complies with GMP and regulatory requirements.
• Engineering Team: Assists with the setup, calibration, and maintenance of the equipment used in gelatin solution preparation to ensure accurate and consistent operation during the validation process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the gelatin solution preparation process is validated and meets the required standards. The QA Manager is responsible for reviewing and approving the validation results and ensuring that the process is compliant with GMP.

5. Procedure

5.1 Preparation for Gelatin Solution Validation

Before starting the validation, ensure the following preparations are made:

1. Review Validation Plan
   1. Review the gelatin solution validation plan, which includes the objectives, materials, equipment, personnel, and the criteria for validation acceptance.
   2. Ensure that the validation plan is approved by the QA department before proceeding with any activities.
2. Gather Materials and Equipment
   1. Ensure that all required materials, including gelatin, water, and other excipients, are available and meet the specified quality standards.
   2. Prepare all equipment used in the gelatin solution preparation process, ensuring that they are cleaned, calibrated, and ready for use.
3. Verify Equipment Calibration
   1. Verify that all equipment used in the preparation process, such as mixers, scales, and pH meters, is calibrated according to the calibration schedule. Record this in the Equipment Calibration Log (Annexure-1).

5.2 Validation Process for Gelatin Solution Preparation

Follow these steps to validate the gelatin solution preparation process:

1. Prepare Gelatin Solution
   1. Weigh and measure the appropriate quantities of gelatin and water according to the formulation requirements.
   2. Mix the gelatin and water at the specified temperature and stirring speed to ensure proper dissolution.
   3. Ensure that the mixture is homogeneous and free from any lumps or un-dissolved material.
2. Monitor Key Process Parameters
   1. Monitor critical process parameters such as temperature, mixing time, and viscosity to ensure consistency and to meet the specifications outlined in the validation plan.
   2. Record all parameters in the Gelatin Solution Preparation Log (Annexure-2).
3. Quality Control Testing
   1. Perform QC tests on the gelatin solution at specified intervals. Tests include measuring viscosity, pH, and clarity to ensure the solution meets the required specifications.
   2. Record the results in the Gelatin Solution QC Report (Annexure-3).
4. Assess and Approve Gelatin Solution
   1. If the gelatin solution meets all the acceptance criteria, it can be approved for use in capsule shell preparation.
   2. If the solution does not meet the specifications, troubleshoot the process, and take corrective actions. Document all actions taken.

5.3 Post-Validation Documentation

Ensure proper documentation of the validation process:

1. Gelatin Solution Validation Report
   1. Prepare the Gelatin Solution Validation Report (Annexure-4) that summarizes the validation activities, including the materials used, equipment, process parameters, test results, and conclusions.
2. Review and Approval
   1. Review the validation report and ensure all data is consistent with the validation criteria. The report should be approved by the QA Manager before proceeding with normal production.

5.4 Documentation

Ensure proper documentation of the process validation for traceability and future reference:

1. Gelatin Solution Preparation Log
   1. Document the preparation details for each batch of gelatin solution, including the quantities used, preparation steps, and any observations during the process.
2. Gelatin Solution QC Report
   1. Complete the QC report to document the results of the quality control tests conducted on the gelatin solution.
3. Process Validation Report
   1. Document the process validation results, including the validation plan, process parameters, and any corrective actions taken during the validation process.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• pH: Potential of Hydrogen
• RPM: Revolutions Per Minute

7. Documents

1. Gelatin Solution Preparation Log (Annexure-2)
2. Gelatin Solution QC Report (Annexure-3)
3. Gelatin Solution Validation Report (Annexure-4)
4. Equipment Calibration Log (Annexure-1)

8. References

• USP <1163> – Pharmaceutical Dosage Forms: Capsules
• FDA Guidelines for Capsule Manufacturing
• Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-2: Gelatin Solution Preparation Log

Batch ID	Preparation Date	Operator	Ingredients Used	Preparation Notes
Batch 001	02/02/2025	John Doe	Gelatin, water	Properly mixed, no lumps observed

Annexure-3: Gelatin Solution QC Report

Batch ID	Test Date	Viscosity	pH	Clarity	Remarks
Batch 001	02/02/2025	500 cP	5.5	Clear	Pass

Annexure-4: Gelatin Solution Validation Report

Batch ID	Validation Date	Operator	Test Parameters	Results
Batch 001	02/02/2025	Jane Smith	Viscosity, pH, Clarity	Within specifications

Annexure-1: Equipment Calibration Log

Equipment ID	Calibration Date	Operator	Calibration Details	Next Calibration Due
Mixing Machine 001	02/02/2025	Jane Smith	Calibrated for mixing speed and temperature	02/02/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial version	New SOP Creation	QA Head
01/02/2025	2.0	Updated gelatin solution preparation process	Improved validation controls	QA Head