implementing this SOP in compliance with cosmetic GMP regulations.

5. Procedure

5.1 Personnel and Hygiene Requirements

1. All personnel involved in the process must be trained in cosmetic GMP.
2. Personal hygiene standards including protective clothing, gloves, and hairnets must be maintained.
3. Health status of employees should be monitored and documented.

5.2 Facility and Equipment Controls

1. Manufacturing areas must be segregated and cleaned as per cleaning SOP/GM/072/2025.
2. Ensure maintenance and calibration of equipment used in gel manufacturing.
3. Environmental controls must include temperature, humidity, and air quality checks.

5.3 Raw Material Handling

1. Only approved cosmetic-grade raw materials shall be used.
2. All materials must be stored under labeled conditions in designated areas.
3. Maintain traceability through batch records and purchase documentation.

5.4 Manufacturing Controls

1. Follow defined process parameters (e.g., mixing time, temperature) for each gel batch.
2. Document each step in the Batch Manufacturing Record (BMR).
3. Apply in-process checks such as viscosity, appearance, and odor at designated intervals.

5.5 Packaging and Labeling

1. Use pre-approved packaging materials conforming to cosmetic standards.
2. Ensure correct labeling including batch number, Mfg/Exp date, usage instructions, and warnings.
3. Perform label reconciliation and documentation after each batch.

5.6 Quality Control and Release

1. Perform final testing for pH, microbial count, physical appearance, and heavy metals as applicable.
2. Maintain Certificate of Analysis (CoA) for each batch.
3. Only QA-approved batches shall be released for distribution.

5.7 Documentation and Record Keeping

1. Maintain all records for at least 3 years from date of manufacture.
2. Ensure records are legible, dated, and signed by authorized personnel.
3. Records include BMR, cleaning logs, calibration reports, and training files.

6. Abbreviations

• GMP: Good Manufacturing Practice
• BMR: Batch Manufacturing Record
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Batch Manufacturing Record – Annexure-1
2. Training Record Sheet – Annexure-2
3. Environmental Monitoring Log – Annexure-3
4. Label Reconciliation Sheet – Annexure-4
5. CoA Template for Cosmetic Gels – Annexure-5

8. References

• ISO 22716 – Guidelines on Good Manufacturing Practices for Cosmetic Products
• IS 4707 Part 2: List of raw materials generally not recognized as safe
• Schedule S – Drugs and Cosmetics Act, India

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: Batch Manufacturing Record

Batch No.	Product Name	Date	Formulator	QA Reviewer

Annexure-2: Training Record Sheet

Employee Name	Department	Training Date	Trainer	Signature

Annexure-3: Environmental Monitoring Log

Date	Area Monitored	Temperature (°C)	Humidity (%)	Monitored By

Annexure-4: Label Reconciliation Sheet

Label Type	Issued	Used	Returned	Destroyed	Verified By

Annexure-5: CoA Template for Cosmetic Gels

Test	Specification	Result	QC Analyst
Appearance	Clear/Translucent
pH	5.5 – 7.5
Microbial Count	< 100 CFU/g

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
01/05/2022	1.0	Initial version	New SOP	QA Manager
10/06/2025	2.0	Updated Annexures and references to ISO 22716	Regulatory Update	QA Head