Procedure for Formulation Development of Ointments

Department	Research and Development (R&D)/Quality Assurance
SOP No.	FD-011
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 the formulation development of ointments. This ensures that the developed formulation meets efficacy, stability, and regulatory requirements.

2. Scope

This SOP applies to the Research and Development (R&D) department responsible for developing new ointment formulations. It includes ingredient selection, preliminary formulation trials, stability testing, and process optimization.

3. Responsibilities

• Formulation Scientist: Develops and optimizes the ointment formulation.
• Analytical Chemist: Conducts stability testing and compatibility studies.
• Quality Assurance (QA) Personnel: Ensures compliance with regulatory standards.
• Research and Development (R&D) Head: Approves the final formulation for further development.

4. Accountability

The R&D Manager is accountable for ensuring that all formulation trials and documentation are conducted as per regulatory and company standards.

5. Procedure

5.1 Selection of Ingredients

• Identify and select active pharmaceutical ingredients (APIs) based on therapeutic efficacy.
• Choose appropriate excipients, including emulsifiers, humectants, and preservatives.
• Ensure all ingredients comply with pharmacopeial standards (USP, BP, IP).

5.2 Preliminary Formulation Trials

• Prepare small-scale batches with varying compositions.
• Evaluate texture, spreadability, and initial stability.
• Adjust ingredient ratios to achieve the desired properties.

5.3 Stability Testing

• Conduct accelerated stability testing at different temperature and humidity conditions.
• Analyze physical, chemical, and microbial stability parameters.
• Document any formulation changes required based on test results.

5.4 Process Optimization

• Define critical processing parameters such as mixing speed and temperature.
• Optimize heating, cooling, and homogenization processes.
• Conduct pilot-scale trials to validate formulation robustness.

5.5 Documentation and Approval

• Document all formulation trials, test results, and modifications.
• Prepare a formulation development report.
• Obtain final approval from the R&D Head before proceeding to pilot batch production.

6. Abbreviations

• API – Active Pharmaceutical Ingredient
• USP – United States Pharmacopeia
• BP – British Pharmacopeia
• IP – Indian Pharmacopeia
• QA – Quality Assurance
• R&D – Research and Development

7. Documents

• Formulation Development Report (Annexure-1)
• Stability Testing Report (Annexure-2)

8. References

• ICH Q1A (R2) Stability Testing Guidelines
• WHO GMP Guidelines for Pharmaceutical Manufacturing
• 21 CFR Part 211 – Current Good Manufacturing Practices

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Formulation Development Report

Date	Batch Number	API Name	Excipients Used	Test Parameters	Result
01/02/2025	F-001	API-A	Emulsifier, Preservative	pH, Viscosity	Pass
02/02/2025	F-002	API-B	Humectant, Stabilizer	Spreadability, Stability	Pass

Annexure-2: Stability Testing Report

Date	Batch Number	Storage Condition	Tested Parameter	Result	Verified By
01/02/2025	F-001	25°C/60% RH	Viscosity	Stable	QA Officer
02/02/2025	F-002	40°C/75% RH	pH	Acceptable	QA Officer

12. Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By	Page No.	Ref. Point No.	Details of Revision
01/01/2024	1.0	Initial Version	New SOP	QA Head	All	All	Created new SOP
01/02/2025	2.0	Updated SOP Format	Standardization of Document	QA Head	All	All	Revised to meet new documentation standards