Standard Operating Procedure for Formulation Development of Creams

Department	Creams
SOP No.	SOP/CRM/021/2025
Supersedes	SOP/CRM/021/2022
Page No.	Page 1 of 6
Issue Date	10/06/2025
Effective Date	15/06/2025
Review Date	10/06/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide a structured approach for developing formulations of creams in the Creams Department. This includes defining the steps, responsibilities, and criteria to ensure that new formulations meet quality, safety, regulatory, and efficacy standards.

2. Scope

This SOP applies to the formulation development of all cream products within the Creams Department. It covers the processes involved from initial formulation development to batch scaling and optimization for commercialization.

3. Responsibilities

• Formulation Development Team: Responsible for designing, optimizing, and validating cream formulations in compliance with regulatory standards and internal quality systems.
• Quality Control (QC): Responsible for conducting stability testing, evaluating the physical and chemical properties of cream formulations, and ensuring all specifications are met.
• Quality Assurance (QA): Responsible for overseeing compliance with this SOP, ensuring the formulation process is properly documented, and that all products meet safety, efficacy, and regulatory requirements.
• Regulatory Affairs: Ensures that the formulation meets all local and international regulatory standards before approval for commercialization.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing formulation development. The QA Manager is accountable for ensuring compliance with this SOP and reviewing all documentation related to formulation development.

5. Procedure

5.1 Initial Research and Formulation Design

1. Conduct a comprehensive review of the intended product’s therapeutic objectives, target market, and regulatory requirements.
2. Select appropriate active ingredients (APIs), excipients, preservatives, colorants, and fragrances based on the intended use of the cream (e.g., moisturizing, anti-aging, therapeutic, etc.).
3. Determine the formulation type (e.g., oil-in-water, water-in-oil, anhydrous) based on the intended benefits and stability requirements.
4. Define the required concentration of each ingredient, ensuring it is within the regulatory limits and optimized for performance.

5.2 Formulation Development and Laboratory Scale Preparation

1. Prepare the first batch of the cream formulation in the laboratory under controlled conditions, following the determined formulation parameters.
2. Use appropriate equipment such as mixers, homogenizers, and temperature-controlled vessels to ensure uniformity and consistency in the preparation.
3. After preparing the batch, conduct initial visual inspections to check for consistency, appearance, and homogeneity.
4. Perform preliminary physical tests such as pH, viscosity, and texture to ensure the formulation meets the desired characteristics.

5.3 Stability and Compatibility Testing

1. Submit the laboratory-scale formulation for stability testing under controlled conditions (e.g., accelerated, long-term storage).
2. Conduct compatibility studies to ensure that the formulation’s components remain stable and do not interact negatively under various conditions (e.g., temperature, light, humidity).
3. Adjust the formulation as needed based on test results (e.g., altering ingredient concentrations, modifying emulsifiers).

5.4 Pilot Scale Batch Preparation

1. Once the formulation has passed laboratory-scale testing, prepare a pilot-scale batch to evaluate scalability and production feasibility.
2. Use production equipment and follow standard operating procedures (SOPs) to ensure the process mimics full-scale manufacturing conditions.
3. Perform testing on the pilot batch to confirm that the formulation can be consistently replicated on a larger scale.
4. Evaluate key performance metrics such as batch uniformity, consistency, and stability over time in the pilot batch.

5.5 Scale-Up and Commercial Production

1. After successful pilot batch evaluation, scale-up the formulation for commercial production, ensuring that the equipment, process, and formulation remain consistent.
2. Review the production process for efficiency, consistency, and cost-effectiveness while maintaining quality standards.
3. Perform a final round of stability and quality control tests to ensure the commercial batch meets the required specifications.
4. Validate the formulation through stability studies and other required testing to ensure the product is ready for release.

5.6 Documentation and Regulatory Submission

1. Prepare comprehensive documentation on the formulation, including the formulation development process, testing results, batch records, and any stability or compatibility reports.
2. Submit the formulation details, batch records, and any required testing results to the regulatory authorities for approval prior to commercial release.
3. Ensure all product labels, claims, and packaging are compliant with regulatory requirements.

5.7 Final Review and Approval

1. The formulation development process is considered complete when the QA and Regulatory Affairs teams have reviewed and approved all documentation, testing, and formulations.
2. Once approved, the product can proceed to mass production and commercial distribution.

6. Abbreviations

• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• GMP: Good Manufacturing Practices

7. Documents

1. Formulation Development Log (Annexure-1)
2. Stability Testing Report (Annexure-2)
3. Pilot Batch Report (Annexure-3)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Internal SOP for Stability Testing and Product Development

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 Log

Formulation Name	Batch Number	Ingredients	Process Details	Testing Results
Moisturizing Cream	12345	Water, Glycerin, Aloe Vera	Mixing, Heating, Homogenization	Passed viscosity, stability tests

Annexure-2: Stability Testing Report

Test Type	Test Result	Test Date	Approval Status
Accelerated Stability	Pass	01/06/2025	Approved

Annexure-3: Pilot Batch Report

Batch Number	Production Date	Test Results	Approval Status
12345	02/06/2025	Passed all tests	Approved for Scale-Up

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head