Standard Operating Procedure for Finalizing Master Formula Records for Cream Products
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/040/2025 |
| Supersedes | SOP/CRM/040/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 13/09/2025 |
| Effective Date | 18/09/2025 |
| Review Date | 13/09/2026 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for finalizing the Master Formula Record (MFR) for cream products. The MFR serves as the blueprint for the production process, ensuring that each batch of cream is manufactured consistently and in compliance with regulatory and quality standards.
2. Scope
This SOP applies to the formulation and production of all cream products within the Creams Department. It outlines the process for creating, reviewing, and finalizing the Master Formula Record, which includes all critical information necessary for production, such as ingredients, formulation steps, process parameters, and quality control specifications.
3. Responsibilities
- Formulation Development Team: Responsible for creating the initial draft of the Master Formula Record, which includes formulation details, ingredient specifications, and process steps.
- Quality Control (QC): Responsible for reviewing the MFR to ensure that it includes all necessary quality control tests and specifications. QC must also verify that all testing methods are aligned with regulatory requirements.
- Quality Assurance (QA): Ensures the accuracy, completeness, and compliance of the Master Formula Record with GMP guidelines. QA also manages the final approval process of the MFR.
- Production Team: Implements the finalized MFR during manufacturing, ensuring that each batch adheres to the process outlined in the MFR.
4. Accountability
The Head of Creams Manufacturing is responsible for overseeing the finalization of the Master Formula Record and ensuring that it meets the necessary quality and regulatory standards. The QA Manager is accountable for approving the MFR before it is used for production.
5. Procedure
5.1 Initial Drafting of the Master Formula Record
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The Formulation Development Team is responsible for creating the first draft of the MFR. This draft should include the following:
- Product name and description
- List of ingredients, including the concentration and grade of each
- Step-by-step instructions for the manufacturing process, including mixing, heating, cooling, and other critical operations
- Quality control specifications, such as acceptable limits for pH, viscosity, and microbial contamination
- Packaging requirements and specifications
- The draft MFR should be reviewed by the Formulation Development Team to ensure that all necessary information is included and accurately reflects the intended formulation and manufacturing process.
5.2 Review by Quality Control (QC)
- Once the initial draft is complete, the QC team reviews the MFR for compliance with quality control standards. This includes verifying that all required quality control tests (e.g., stability, microbiological testing, packaging) are included in the MFR.
- QC checks the accuracy of ingredient specifications and ensures that the limits for each quality attribute (e.g., pH, viscosity, microbial limits) are in line with industry standards and regulatory requirements.
- QC should also review the manufacturing process to ensure that it is in compliance with GMP guidelines and that critical process parameters (CPPs) are well-defined and measurable.
- Any discrepancies or missing information should be addressed by the Formulation Development Team and resubmitted to QC for further review.
5.3 Final Review by Quality Assurance (QA)
- Once QC has completed their review and the necessary corrections have been made, the final version of the MFR is submitted to QA for approval.
- QA verifies that the MFR complies with all applicable regulatory requirements, including those set by the FDA, ICH, or any other relevant bodies. QA also ensures that the MFR contains all the necessary information for manufacturing and quality control.
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QA ensures that the MFR includes:
- Correct identification and description of the product
- Complete and accurate ingredient list, including their functional role in the formulation
- Manufacturing instructions that are clear and precise
- Accurate quality control specifications, including test methods and acceptance criteria
- QA ensures that the document is signed off and formally approved by the necessary stakeholders, including the Head of Manufacturing and the QA Manager.
5.4 Approval and Issuance of the Master Formula Record
- After QA approval, the finalized MFR is issued for use in production. The MFR is considered a controlled document, and it must be stored in the Document Control System.
- A copy of the MFR should be provided to the Production Team, which will use it as the primary reference document for manufacturing the cream product.
- Ensure that the MFR is reviewed and updated periodically to account for any changes in the formulation or manufacturing process.
5.5 Documentation and Record-Keeping
- The final MFR must be documented and stored in a controlled document system. This ensures that the MFR is easily accessible for reference during production, audits, and inspections.
- Maintain records of all revisions to the MFR, including the reasons for revisions, and the approval status of each version.
- All versions of the MFR should be retained for the duration of the product’s shelf life or as required by regulatory agencies.
5.6 Final Approval and Commercial Production
- Once the MFR is finalized and approved, it is used as the basis for commercial production. The Production Team should ensure that each batch produced follows the MFR’s instructions exactly.
- Any deviations from the MFR during production must be documented, and corrective actions should be taken to ensure that the final product meets the quality standards outlined in the MFR.
- The MFR must be revisited for review if there are significant changes in the formulation or process, or if regulatory requirements change.
6. Abbreviations
- QC: Quality Control
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- API: Active Pharmaceutical Ingredient
- MFR: Master Formula Record
7. Documents
- Master Formula Record (MFR) Template (Annexure-1)
- Formulation Development Log (Annexure-2)
- Batch Record (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
- FDA Guidelines for Cosmetics Manufacturing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Master Formula Record Template
| Product Name | Ingredients | Process Steps | QC Specifications |
|---|---|---|---|
| Moisturizing Cream | Water, Glycerin, Hyaluronic Acid | Mix, Heat to 65°C, Cool to 25°C | pH 5.5-6.5, Viscosity 3000-3500 cP |
Annexure-2: Formulation Development Log
| Formulation Name | Batch Number | Ingredients | Process Parameters |
|---|---|---|---|
| Moisturizing Cream | 67890 | Water, Glycerin, Hyaluronic Acid | Mixing: 30 min, Temperature: 65°C |
Annexure-3: Batch Record
| Batch Number | Test Date | QC Result | Approval Status |
|---|---|---|---|
| 12345 | 15/09/2025 | Pass (pH 5.6, Viscosity 3200 cP) | Approved |
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 |