premises meet GMP requirements.

QC Department: Conduct quality tests on raw materials, in-process gels, and final products.

4. Accountability

The Head of Gel Manufacturing is accountable for overall GMP compliance and quality of cosmetic gel products.

5. Procedure

5.1 Premises and Hygiene

1. Ensure that premises are clean, well-maintained, and equipped with appropriate ventilation and lighting.
2. Implement daily and weekly cleaning schedules and maintain records.
3. Design workflows to minimize cross-contamination and human error.

5.2 Personnel Hygiene and Training

1. Mandate daily hygiene checks for all personnel entering production and QC areas.
2. Provide GMP training every 6 months and maintain attendance records.
3. Enforce use of PPE such as gloves, gowns, head covers, and face masks.

5.3 Equipment and Utilities

1. Clean and sanitize all equipment before and after each batch.
2. Calibrate weighing balances, pH meters, viscometers, and other equipment as per schedule.
3. Use filtered water systems validated for cosmetic manufacturing.

5.4 Raw Materials Management

1. Use only approved raw materials that meet pharmacopeial or cosmetic-grade specifications.
2. Segregate incoming raw materials into quarantine, approved, and rejected zones.
3. Label raw materials with batch numbers, expiry dates, and storage instructions.

5.5 Manufacturing Practices

1. Document each manufacturing step in a dedicated Batch Manufacturing Record (BMR).
2. Perform in-process checks for pH, viscosity, and appearance.
3. Avoid overheating thermolabile excipients during mixing.

5.6 Packaging and Labelling

1. Conduct line clearance before starting packaging activities.
2. Use tamper-evident packaging materials and ensure proper labeling.
3. Verify label compliance with cosmetic labeling regulations, including ingredients and batch numbers.

5.7 Quality Control and Product Release

1. Test each batch for microbial limits, heavy metals, and preservatives’ efficacy.
2. Retain reference samples and COA for every batch.
3. QA shall authorize release only after all specifications are met.

5.8 Documentation and Records

1. Maintain batch records, cleaning logs, calibration reports, and deviation logs for a minimum of 3 years.
2. Use controlled document formats with version control and approval signatures.

6. Abbreviations

• GMP: Good Manufacturing Practice
• QA: Quality Assurance
• QC: Quality Control
• PPE: Personal Protective Equipment
• BMR: Batch Manufacturing Record

7. Documents

1. Batch Manufacturing Record – Annexure-1
2. Personnel Hygiene Checklist – Annexure-2
3. Cleaning Log Sheet – Annexure-3
4. Calibration Log – Annexure-4
5. Raw Material Receipt Register – Annexure-5

8. References

• ISO 22716 – Guidelines on Good Manufacturing Practices for Cosmetic Products
• Schedule M – Cosmetics (India)
• US FDA Cosmetic GMP Guidelines

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

Product Name
Batch No.
Date of Manufacture
Expiry Date
Process Details
Operator Signature

Annexure-2: Personnel Hygiene Checklist

Employee Name	Date	Hands Washed	PPE Worn	Approved to Enter

Annexure-3: Cleaning Log Sheet

Area/Equipment	Date	Cleaned By	Checked By	Remarks

Annexure-4: Calibration Log

Instrument Name	Calibration Date	Next Due	Calibrated By	Status

Annexure-5: Raw Material Receipt Register

Material Name	Batch No.	Vendor	Date Received	Status

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
25/04/2022	1.0	Initial release	New SOP	QA Head
09/06/2025	2.0	Updated to align with ISO 22716	Periodic review	QA Head