Standard Operating Procedure for Adjusting Gelatin Composition for Seasonal Variations

Department	Capsule Manufacturing
SOP No.	SOP/CM/106/2025
Supersedes	SOP/CM/106/2022
Page No.	Page 1 of 6
Issue Date	01/02/2025
Effective Date	05/02/2025
Review Date	01/02/2026

1. Purpose

The purpose of this SOP is to outline the procedure for adjusting gelatin composition in capsule manufacturing to account for seasonal variations in environmental conditions. Changes in temperature, humidity, and other factors during different seasons can affect the properties of gelatin, necessitating adjustments to maintain product quality.

2. Scope

This SOP applies to all gelatin-based capsule manufacturing processes where the composition may need to be adjusted based on seasonal variations. It includes adjustments to gelatin concentration, additives, and processing conditions.

3. Responsibilities

• Production Operators: Responsible for implementing the adjustments to the gelatin composition according to the SOP and ensuring consistent quality during production.
• Quality Control (QC) Team: Responsible for monitoring the properties of the gelatin and conducting tests to verify the suitability of the adjusted composition.
• Quality Assurance (QA) Team: Ensures that all adjustments are documented and that the production process complies with regulatory standards. Reviews and approves the adjusted gelatin composition.
• Production Supervisor: Oversees the entire process, ensures that adjustments are made correctly, and coordinates between production, QC, and QA teams.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that adjustments to the gelatin composition are made in compliance with this SOP. The QA Manager is responsible for verifying the adjustments and reviewing the final product for compliance with quality standards.

5. Procedure

5.1 Identifying Seasonal Variations

To determine the need for adjusting gelatin composition, monitor the environmental conditions and identify any seasonal variations that may affect the manufacturing process:

1. Monitor Temperature and Humidity
   1. Track temperature and humidity levels in the production area to identify seasonal fluctuations. Ensure that the production environment is within the ideal range for gelatin processing.
   2. Document these environmental conditions regularly in the Environmental Monitoring Log (Annexure-1).
2. Evaluate Gelatin Properties
   1. Regularly assess the properties of the gelatin, including its viscosity, moisture content, and solubility, to determine if seasonal variations are affecting the material.
   2. Record observations in the Gelatin Properties Log (Annexure-2) to track trends over time.

5.2 Adjusting Gelatin Composition

Once seasonal variations have been identified, adjust the gelatin composition accordingly to maintain product quality:

1. Adjust Gelatin Concentration
   1. Increase or decrease the gelatin concentration as needed based on temperature and humidity. Higher humidity may require reducing the gelatin concentration to maintain consistency, while lower humidity may require an increase.
   2. Consult with the R&D or formulation team to determine the ideal concentration for the current environmental conditions.
2. Modify Additives
   1. Adjust the quantity of plasticizers, stabilizers, or other additives to compensate for changes in gelatin properties caused by seasonal changes.
   2. Ensure that the adjusted additives do not affect the final capsule’s quality or stability.
3. Monitor Gelatin Melting Point
   1. Check the melting point of the gelatin regularly during seasonal transitions, as changes in temperature may affect the gelatin’s behavior during encapsulation.
   2. Adjust the encapsulation temperature if necessary to ensure proper sealing of the capsules.

5.3 Conducting Quality Control Tests

After adjusting the gelatin composition, conduct the necessary quality control tests to verify that the adjustments have not negatively impacted the quality of the capsules:

1. Gelatin Testing
   1. Perform tests on the gelatin to ensure that it meets the required viscosity, solubility, and gel strength. This ensures that the gelatin will perform properly during capsule filling and sealing.
   2. Document test results in the Gelatin Quality Control Log (Annexure-3).
2. Capsule Testing
   1. Conduct tests on filled capsules to ensure that they meet the necessary specifications for weight, size, fill volume, and sealing integrity.
   2. If the capsules do not meet specifications, revisit the adjustments to the gelatin composition and make further refinements.

5.4 Monitoring Production

Monitor the production process to ensure that the adjusted gelatin composition is functioning as intended:

1. Observe Gelatin Flow
   1. Monitor the flow of the gelatin during capsule filling to ensure smooth processing without clogging or irregular filling.
   2. Document any irregularities in the Gelatin Flow Log (Annexure-4) and adjust the composition as needed to maintain optimal flow.
2. Monitor Capsule Sealing
   1. Check the capsule sealing process to ensure that the adjusted gelatin composition provides a strong and consistent seal. This is especially important during colder weather when gelatin may become more brittle.

5.5 Final Approval and Release

Once the gelatin composition adjustments have been made and the production process is running smoothly, proceed with the following steps:

1. QA Review
   1. The QA team should review all records, including quality control tests, batch records, and adjustments made to the gelatin composition, to ensure compliance with the required standards.
2. Approval for Production
   1. If the adjusted gelatin composition is verified to meet the required specifications, approve the batch for continued production and packaging.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance

7. Documents

1. Gelatin Properties Log (Annexure-2)
2. Gelatin Quality Control Log (Annexure-3)
3. Gelatin Flow Log (Annexure-4)
4. Batch Records (Annexure-5)

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-1: Environmental Monitoring Log

Date	Temperature (°C)	Humidity (%)	Operator
01/02/2025	22°C	55%	John Doe

Annexure-2: Gelatin Properties Log

Date	Viscosity (cP)	Moisture Content (%)	Solubility (%)	Operator
01/02/2025	300	13%	98%	Jane Smith

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 adjustment procedures	Seasonal Variation Adaptation	QA Head