Standard Operating Procedure for Documentation in Product Development of Creams

Department	Creams
SOP No.	SOP/CRM/030/2025
Supersedes	SOP/CRM/030/2022
Page No.	Page 1 of 6
Issue Date	25/07/2025
Effective Date	30/07/2025
Review Date	25/07/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the process for proper documentation throughout the product development lifecycle of cream formulations. Accurate documentation ensures compliance with regulatory requirements, traceability of all product development activities, and the availability of information for future reference and audits.

2. Scope

This SOP applies to all documentation activities related to the development of cream formulations within the Creams Department. It covers the creation, maintenance, storage, and retrieval of all documentation generated during product development, including formulation records, testing data, stability studies, and regulatory submissions.

3. Responsibilities

• Formulation Development Team: Responsible for creating and maintaining detailed records of formulation activities, ingredient selections, and testing protocols.
• Quality Control (QC): Responsible for documenting all analytical and stability testing, including raw data, test results, and any deviations from expected results.
• Quality Assurance (QA): Ensures that all documentation complies with regulatory requirements and internal standards, and oversees document control and approval processes.
• Regulatory Affairs: Ensures that all documentation meets regulatory requirements for submission to regulatory authorities for approval.

4. Accountability

The Head of Creams Manufacturing is responsible for overseeing the documentation process within the department. The QA Manager is accountable for ensuring that all documents are properly controlled, reviewed, and approved, in compliance with regulatory and internal standards.

5. Procedure

5.1 Document Creation and Control

1. All documents related to product development must be created and maintained in accordance with GMP guidelines. These documents include, but are not limited to:
   • Formulation records
   • Batch records
   • Test results and stability studies
   • Regulatory submissions and approvals
2. Ensure that documents are accurate, complete, and reflect the true nature of the product development process.
3. Documents should be created using standard templates or formats as provided by the QA department to ensure consistency and completeness.
4. All documents must be clearly labeled with a version number, date, and the author’s details to ensure traceability and accountability.
5. Implement a document control system that ensures all documents are appropriately reviewed, approved, and updated as needed.

5.2 Document Review and Approval

1. All documents must undergo a review and approval process to ensure that they are accurate, complete, and comply with regulatory standards.
2. The Formulation Development Team is responsible for preparing the documentation and submitting it for review to the QA team.
3. The QA team will review the documents for compliance with internal procedures and regulatory requirements. If necessary, the documents will be returned to the Formulation Development Team for revisions.
4. Once approved, the documents should be signed and dated by the authorized personnel, and stored in a secure and accessible location.

5.3 Documentation of Formulation Records

1. Create detailed formulation records that include all relevant information, such as:
   • List of all ingredients used (including suppliers, lot numbers, and specifications)
   • Concentrations and quantities of each ingredient
   • Preparation method, including equipment and process parameters (e.g., temperature, mixing speed)
   • Notes on any deviations from the standard procedure
   • Record of testing results (e.g., pH, viscosity, stability)
2. Maintain these records throughout the product development lifecycle, from initial formulation to final approval for production.

5.4 Documentation of Testing and Stability Studies

1. All testing and stability studies conducted on cream formulations must be documented in detail, including:
   • Type of test (e.g., viscosity, stability, microbial testing)
   • Test methods used and equipment employed
   • Results, including any deviations from expected results
   • Actions taken to address any issues identified during testing (e.g., formulation adjustments)
   • Test dates and personnel involved
2. Store raw data and test reports securely, ensuring they are easily accessible for future reference or audits.

5.5 Documentation of Regulatory Submissions

1. Document all communications and submissions to regulatory authorities, including:
   • Submission forms and templates used for regulatory applications
   • Approval or feedback from regulatory bodies
   • Any additional documentation required by the regulatory authorities (e.g., safety data, efficacy studies)
2. Ensure that all regulatory submissions are tracked and that responses are documented and reviewed for compliance.

5.6 Record Retention and Storage

1. All documentation must be stored in accordance with regulatory and internal guidelines. This includes:
   • Physical storage of hard copy documents in secure, organized filing systems
   • Electronic storage of digital documents in a secure document management system
   • Retention of documents for the required duration as per regulatory and company policies
2. Ensure that documents are easily retrievable for audits or regulatory inspections.

5.7 Document Destruction

1. Once the required retention period has elapsed, documents should be disposed of in a manner that ensures confidentiality and security.
2. Ensure that document destruction is properly documented and approved by authorized personnel.

6. Abbreviations

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

7. Documents

1. Formulation Records (Annexure-1)
2. Stability Testing Report (Annexure-2)
3. Regulatory Submission 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
• FDA Guidelines for Documentation and Record Keeping

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 Records

Formulation Name	Batch Number	Ingredients	Process Parameters	Test Results
Hydrating Cream	12345	Water, Glycerin, Hyaluronic Acid	Mixing: 30 min, Temperature: 65°C	Viscosity: Pass, pH: Pass

Annexure-2: Stability Testing Report

Test Type	Test Result	Test Date	Approval Status
Real-time Stability	Pass	25/07/2025	Approved

Annexure-3: Regulatory Submission Log

Submission Date	Regulatory Body	Submission Type	Status
01/08/2025	FDA	Product Registration	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