Procedure for Ensuring Proper Dispersion of Active Ingredients
| Department | Manufacturing/Production/Quality Assurance (QA)/Quality Control (QC)/Research and Development (R&D) |
|---|---|
| SOP No. | SOP/Ointment/195 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for ensuring the proper dispersion of active ingredients in ointment formulations. Proper dispersion is crucial to maintaining uniformity, product stability, and therapeutic effectiveness.
2. Scope
This SOP applies to all personnel involved in the handling, preparation, mixing, and quality control of active ingredients in ointment manufacturing within the Manufacturing, Production, Quality Assurance (QA), Quality Control (QC), and Research and Development (R&D) departments.
3. Responsibilities
- Production Supervisor: Ensures compliance with the active ingredient dispersion process.
- Process Operator: Monitors and controls the mixing conditions for uniform dispersion.
- QA Officer: Verifies uniformity and adherence to dispersion protocols.
- QC Analyst: Conducts testing to confirm proper distribution of active ingredients.
- Maintenance Engineer: Ensures mixing equipment operates within defined specifications.
4. Accountability
The Production Manager is accountable for ensuring that all active ingredient dispersion procedures comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Selection of Active Ingredients
- Ensure that active ingredients meet the required specifications and are within acceptable potency limits.
- Verify the compatibility of active ingredients with the ointment base.
- Document ingredient selection in the **Active Ingredient Selection Log (Annexure-1).**
5.2 Preparation for Dispersion
- Confirm that all active ingredients are properly weighed and documented.
- Ensure that the mixing equipment is calibrated and functioning correctly.
- Record all pre-dispersion checks in the **Pre-Dispersion Checklist (Annexure-2).**
5.3 Dispersion Process
- Introduce active ingredients into the ointment base gradually while mixing at a controlled speed.
- Maintain an optimal **mixing speed of 100-300 RPM** to ensure uniform dispersion.
- If required, pre-disperse active ingredients in a suitable solvent before incorporation.
- Ensure continuous mixing for **20-45 minutes**, depending on the ingredient properties.
- Record dispersion parameters in the **Active Ingredient Dispersion Log (Annexure-3).**
5.4 Quality Control Testing
- Conduct **uniformity testing** using validated analytical methods.
- Perform **particle size analysis** to confirm proper distribution.
- Verify dispersion quality using **microscopic examination.**
- Document all test results in the **Quality Control Testing Log (Annexure-4).**
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Active Ingredient Selection Log (Annexure-1)
- Pre-Dispersion Checklist (Annexure-2)
- Active Ingredient Dispersion Log (Annexure-3)
- Quality Control Testing Log (Annexure-4)
8. References
- ICH Q8 – Pharmaceutical Development Guidelines
- FDA Guidance on Topical Formulation Processing
- WHO Guidelines on Manufacturing Quality Control
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Active Ingredient Selection Log
| Date | Batch No. | Active Ingredient | Specification Met | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | OINT-4001 | Clotrimazole | Yes | Approved |
Annexure-2: Pre-Dispersion Checklist
| Date | Batch No. | Equipment Checked | Ingredients Verified | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | OINT-4001 | Yes | Yes | Approved |
Annexure-3: Active Ingredient Dispersion Log
| Date | Batch No. | Ingredient Added | Mixing Speed (RPM) | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | OINT-4001 | Clotrimazole | 200 RPM | Approved |
Annexure-4: Quality Control Testing Log
| Date | Batch No. | Uniformity Test Result | Particle Size Analysis | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | OINT-4001 | Pass | 98% within range | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Dispersion Guidelines | Regulatory Compliance | QA Head |
| 01/01/2024 | 1.0 | Initial SOP | New SOP Implementation | QA Head |