Standard Operating Procedure for Prototype Batch Development for Creams

Department	Creams
SOP No.	SOP/CRM/025/2025
Supersedes	SOP/CRM/025/2022
Page No.	Page 1 of 6
Issue Date	30/06/2025
Effective Date	05/07/2025
Review Date	30/06/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to define the process for developing prototype batches of cream formulations. Prototype batch development is a critical step in the formulation process, allowing for the evaluation of a cream’s performance, scalability, and manufacturing feasibility before full-scale production begins.

2. Scope

This SOP applies to all cream formulations undergoing prototype batch development within the Creams Department. It covers the preparation, testing, evaluation, and documentation of prototype batches designed to assess product characteristics, stability, and commercial feasibility.

3. Responsibilities

• Formulation Development Team: Responsible for designing the formulation, selecting ingredients, and preparing the prototype batch. The team ensures that the prototype batch meets the desired specifications and product objectives.
• Quality Control (QC): Responsible for performing quality tests, including physical, chemical, and microbial assessments, to evaluate the prototype batch’s characteristics and stability.
• Quality Assurance (QA): Ensures that the prototype batch development process is carried out according to this SOP and that all documentation is completed accurately and complies with GMP standards.
• Production Team: Responsible for scaling up the prototype batch, ensuring that it is produced under controlled conditions for evaluation and testing.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing prototype batch development and ensuring the process adheres to this SOP. The QA Manager is accountable for reviewing the final prototype batch and associated documentation for compliance.

5. Procedure

5.1 Formulation Design and Ingredient Selection

1. The formulation development team must design a cream formulation that aligns with the product’s intended use, market specifications, and regulatory requirements.
2. Select ingredients based on compatibility, efficacy, stability, and regulatory compliance. Ingredients should be chosen to achieve the desired texture, stability, and performance.
3. Review previous formulation data, if available, and adjust ingredient concentrations as necessary to optimize the product’s effectiveness and commercial feasibility.

5.2 Prototype Batch Preparation

1. Prepare a small-scale prototype batch according to the formulation design. Follow all manufacturing procedures, including the mixing, homogenization, and emulsification steps, as specified in the formulation guidelines.
2. Use equipment that mirrors production-scale operations to ensure the prototype batch is representative of the full-scale production process.
3. Record all production parameters, including mixing times, temperatures, and ingredient lot numbers, to maintain traceability and ensure batch consistency.

5.3 Testing and Evaluation of Prototype Batch

1. After the prototype batch is produced, perform the following tests to evaluate product characteristics:
   • Viscosity and texture testing
   • pH and active ingredient concentration analysis
   • Stability testing (e.g., accelerated stability and real-time stability)
   • Microbial testing (if applicable)
2. Evaluate the sensory attributes of the cream, including spreadability, fragrance, and feel. Conduct panel testing if necessary to gather consumer feedback on product performance.
3. Compare the test results to the formulation’s specifications to ensure that the product meets all desired criteria.

5.4 Adjustments and Optimization

1. If the prototype batch does not meet the required specifications, adjust the formulation to address any issues. This may include modifying ingredient concentrations, adjusting processing conditions, or switching ingredients to achieve the desired product characteristics.
2. Once adjustments are made, repeat the prototype batch development and testing process to verify the changes.

5.5 Scale-Up Considerations

1. After confirming that the prototype batch meets the desired specifications, the formulation development team should consider the scalability of the process. Ensure that the formulation can be reproduced in larger quantities without compromising product quality.
2. Work with the production team to conduct small-scale manufacturing runs to assess the feasibility of scaling up the batch.
3. Identify any potential issues that could arise during large-scale production, such as mixing efficiency or ingredient separation, and address these issues before full-scale production begins.

5.6 Documentation and Approval

1. Document all activities during the prototype batch development process, including formulation changes, production parameters, and test results.
2. Prepare a comprehensive Prototype Batch Development Report that includes:
   • Formulation details
   • Batch records
   • Test results
   • Adjustments made
   • Approval status from the QA team
3. The QA team must review and approve the Prototype Batch Development Report before moving forward with scale-up or commercialization.

5.7 Final Review and Commercialization Decision

1. Once the prototype batch is tested, evaluated, and adjusted as necessary, the QA team will review the entire development process and approve the formulation for commercial production.
2. If the prototype batch is successful and meets all product requirements, the formulation can move forward to larger-scale manufacturing and commercialization.
3. If any issues remain unresolved after the prototype batch testing and adjustments, the formulation development team must revisit the formulation design and repeat the prototype development process.

6. Abbreviations

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

7. Documents

1. Prototype Batch Development Log (Annexure-1)
2. Prototype Batch Testing Report (Annexure-2)
3. Formulation Development Log (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 Product Development and Testing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Prototype Batch Development Log

Batch Number	Ingredients	Process Steps	Test Results	Comments
12345	Water, Glycerin, Aloe Vera	Mixing, Heating, Homogenization	Passed all tests	No issues

Annexure-2: Prototype Batch Testing Report

Test Type	Test Result	Test Date	Approval Status
Viscosity	Within specification	01/07/2025	Approved

Annexure-3: Formulation Development Log

Formulation Name	Batch Number	Ingredients	Process Description	Prototype Batch Outcome
Hydrating Cream	12345	Water, Glycerin, Aloe Vera	Mixing, Heating, Homogenization	Successful batch, no adjustments needed

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