Procedure for Incorporating Excipients in Ointment Formulations
| Department | Research and Development (R&D)/Quality Assurance (QA)/Quality Control (QC)/Formulation Development |
|---|---|
| SOP No. | SOP/Ointment/184 |
| 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 establish a systematic approach for selecting, handling, and incorporating excipients in ointment formulations to ensure product stability, efficacy, and compliance with regulatory standards.
2. Scope
This SOP applies to all personnel involved in the selection, handling, weighing, and incorporation of excipients in ointment formulations in the Research and Development (R&D), Quality Assurance (QA), and Quality Control (QC) departments.
3. Responsibilities
- Formulation Scientist: Determines appropriate excipients for ointment formulations.
- QA Officer: Ensures excipient quality and regulatory compliance.
- QC Analyst: Conducts testing to confirm excipient compatibility and stability.
- Production Supervisor: Oversees the proper incorporation of excipients in the batch.
- Regulatory Affairs Specialist: Ensures documentation complies with global standards.
4. Accountability
The R&D Manager is accountable for ensuring that all excipient-related activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Selection of Excipients
- Choose excipients based on:
- Compatibility with Active Pharmaceutical Ingredients (APIs).
- Intended release profile (immediate, sustained, or controlled release).
- Regulatory approval for topical formulations.
- Commonly used excipients include:
- Emulsifiers: Polysorbates, cetyl alcohol, stearyl alcohol.
- Thickening Agents: Carbomers,
hydroxypropyl cellulose, xanthan gum.
Preservatives: Methylparaben, benzalkonium chloride.
Humectants: Glycerin, propylene glycol.
Penetration Enhancers: Oleic acid, dimethyl sulfoxide (DMSO).
Verify that excipients meet **pharmacopeial specifications (USP, BP, Ph. Eur.).**
5.2 Handling and Storage of Excipients
- Ensure excipients are stored in a **controlled environment**:
- Temperature: **15-25°C**
- Humidity: **30-50% RH**
- Label all excipients with:
- Name and grade.
- Batch number.
- Manufacturing and expiration date.
- Record the storage details in the **Excipient Storage Log (Annexure-1).**
5.3 Weighing and Dispensing of Excipients
- Weigh excipients in a **controlled weighing area** to prevent contamination.
- Ensure the **weighing balance is calibrated and validated.**
- Document each excipient’s weight in the **Weighing and Dispensing Log (Annexure-2).**
5.4 Incorporation of Excipients in Ointment Formulations
- Add excipients in a **pre-determined sequence** to ensure uniformity.
- Use a **high-shear mixer or homogenizer** for uniform dispersion.
- Monitor critical process parameters:
- Mixing speed (300-600 rpm).
- Temperature (35-70°C, depending on excipient properties).
- Shear rate for proper emulsification.
- Record process conditions in the **Excipient Incorporation Log (Annexure-3).**
5.5 Compatibility Testing
- Conduct **API-excipient compatibility studies** under stress conditions (40°C / 75% RH).
- Evaluate:
- pH stability.
- Phase separation.
- Degradation of API.
- Document findings in the **Excipient Compatibility Report.**
5.6 Quality Control and Approval
- QC must conduct:
- Viscosity and spreadability tests.
- Microbial limit tests.
- Homogeneity assessment.
- QA must review batch records before approval.
5.7 Periodic Review and Documentation
- Conduct **annual reviews** of excipient quality and sourcing.
- Maintain records for **five years** for regulatory compliance.
6. Abbreviations
- API – Active Pharmaceutical Ingredient
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Excipient Storage Log (Annexure-1)
- Weighing and Dispensing Log (Annexure-2)
- Excipient Incorporation Log (Annexure-3)
8. References
- ICH Q8 – Pharmaceutical Development Guidelines
- WHO Guidelines on Excipient Selection
- FDA Guidance on Pharmaceutical Excipients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Excipient Storage Log
| Date | Excipient Name | Batch No. | Storage Condition | QA Review |
|---|---|---|---|---|
| 02/02/2025 | Carbomer | EXC-1001 | 25°C / 45% RH | Approved |
Annexure-2: Weighing and Dispensing Log
| Date | Excipient Name | Weighed Quantity | Operator | QA Approval |
|---|---|---|---|---|
| 02/02/2025 | Glycerin | 50 g | John Doe | Approved |