documentation.

Quality Control (QC): Responsible for testing particle size, uniformity, and physical attributes post-manufacture.

4. Accountability

The Head of Manufacturing is accountable for ensuring proper implementation of nanoparticle handling and incorporation procedures as per approved formulation and safety data.

5. Procedure

5.1 Preparation

1. Review the formulation development report and determine the type and specifications of nanoparticles (e.g., silver, gold, zinc oxide, titanium dioxide, liposomes).
2. Verify the Certificate of Analysis (CoA) of nanoparticles and check for sterility, particle size, and heavy metal limits.
3. Ensure proper personal protective equipment (PPE) such as respirators and gloves are used while handling nanoparticles.

5.2 Dispersion of Nanoparticles

1. Transfer the required quantity of nanoparticles to a clean, dry dispersion vessel under laminar airflow.
2. Use a suitable dispersing agent (e.g., polysorbate 80, glycerol) based on formulation compatibility.
3. Utilize ultrasonication or high-shear mixing at defined parameters (RPM and time) to achieve a homogenous nanoparticle dispersion.
4. Conduct particle size analysis and ensure results fall within specification (typically <200 nm).

5.3 Incorporation into Gel Base

1. Ensure the gel base is prepared and cooled to an acceptable temperature (usually <40°C) to avoid nanoparticle degradation.
2. Gradually add the nanoparticle dispersion into the gel base under gentle stirring.
3. Use overhead stirrers to ensure even distribution without introducing air bubbles.
4. Continue mixing until uniformity is visually confirmed and verified through sampling.

5.4 Sampling and Testing

1. Withdraw in-process samples and send to QC for testing:
   • Particle size distribution
   • Uniformity and dispersion homogeneity
   • pH, viscosity, and appearance
2. Proceed to packaging only after release from QC and QA.

5.5 Cleaning and Safety

1. Follow dedicated cleaning procedures for equipment used with nanoparticles as outlined in SOP/GM/078/2025.
2. Dispose of unused or spilled nanoparticles as per hazardous waste guidelines in SOP/EHS/015/2025.

6. Abbreviations

• PPE: Personal Protective Equipment
• R&D: Research and Development
• QA: Quality Assurance
• QC: Quality Control
• CoA: Certificate of Analysis

7. Documents

1. Nanoparticle Dispersion Log – Annexure-1
2. Particle Size Analysis Report – Annexure-2
3. Nanoparticle Handling Record – Annexure-3

8. References

• ICH Q8 – Pharmaceutical Development
• WHO TRS 1025 – Guidelines on Nanotechnology in Pharmaceuticals
• SOP/GM/078/2025 – Equipment Cleaning for Nanoparticle Formulations
• SOP/EHS/015/2025 – Disposal of Hazardous Pharmaceutical Materials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Nanoparticle Dispersion Log

Date	Batch No.	Nanoparticle Type	Quantity	Dispersant Used	Operator Signature

Annexure-2: Particle Size Analysis Report

Date	Batch No.	Sample ID	Mean Particle Size (nm)	Standard Deviation	Performed By

Annexure-3: Nanoparticle Handling Record

Operator	PPE Used	Material Handled	Quantity	Time	Remarks

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
12/04/2022	1.0	Initial issue	New SOP	QA Head
09/06/2025	2.0	Added new types of nanoparticles and dispersion procedure	Annual review	QA Head