Standard Operating Procedure for Quality-by-Design (QbD) in Cream Production

Department	Creams
SOP No.	SOP/CRM/074/2025
Supersedes	SOP/CRM/074/2022
Page No.	Page 1 of 6
Issue Date	21/01/2026
Effective Date	26/01/2026
Review Date	21/01/2027

1. Purpose

The purpose of this SOP is to implement Quality-by-Design (QbD) principles in cream production. QbD is used to ensure that product quality is designed and built into the cream manufacturing process through systematic planning and understanding of critical process parameters (CPPs) and critical quality attributes (CQAs).

2. Scope

This SOP applies to the integration of QbD principles throughout the cream production process. It includes identification, evaluation, and control of critical parameters to ensure consistent product quality and compliance with regulatory requirements.

3. Responsibilities

• Production Team: Responsible for applying QbD principles during production, ensuring that critical parameters are met and documented.
• Quality Control (QC): Ensures that all critical parameters and attributes are tested, monitored, and validated throughout the production process.
• Quality Assurance (QA): Oversees the application of QbD principles, ensures compliance with regulatory standards, and reviews process validation reports.
• R&D Team: Assists in identifying key process variables and product characteristics to be controlled under the QbD framework.

4. Accountability

The Head of Production is accountable for ensuring that QbD principles are integrated into cream production. The QA Manager is responsible for ensuring that the QbD approach meets GMP standards and regulatory guidelines.

5. Procedure

5.1 Identify Critical Quality Attributes (CQAs)

1. Review the formulation and process flow to identify CQAs that impact the final cream product quality (e.g., texture, spreadability, consistency, stability).
2. Ensure that CQAs are aligned with customer expectations, regulatory requirements, and product specifications.
3. Document the identified CQAs and specify acceptable ranges for each parameter.

5.2 Identify Critical Process Parameters (CPPs)

1. Identify the process parameters that affect the CQAs, such as mixing speed, temperature, time, and ingredient ratios.
2. Ensure that all identified CPPs are measurable and controllable during the production process.
3. Define the optimal operating conditions for each CPP based on formulation requirements and previous batch records.

5.3 Process Design and Risk Assessment

1. Perform a risk assessment to determine the impact of each identified CPP on the CQAs. Use tools such as Failure Mode Effects Analysis (FMEA) or Design of Experiments (DOE) to assess the risk of variation in each parameter.
2. Establish control strategies to minimize the risks associated with CPPs, ensuring that the process consistently produces a product that meets the required quality standards.

5.4 Process Control and Monitoring

1. Implement a process monitoring system to continuously measure and control CPPs during the production process. Ensure real-time data is recorded for every batch.
2. Monitor each identified parameter throughout the cream production process, ensuring it remains within defined limits. If any parameters deviate from the set limits, initiate corrective actions.

5.5 Validation and Process Optimization

1. Conduct validation studies to demonstrate that the process is capable of consistently producing products that meet quality standards within the identified CPP ranges.
2. Optimize the process by reviewing batch records, product test results, and feedback from QC to make necessary adjustments and improvements to the production process.

5.6 Documentation

1. Document all findings, including identified CQAs and CPPs, risk assessments, control strategies, and monitoring data.
2. Maintain process validation records and continuous improvement data in the QbD documentation (Annexure-1).
3. Ensure all records are reviewed by QA for compliance with regulatory guidelines and GMP standards.

5.7 Final Approval

1. The QA team must review all QbD documentation, including risk assessments, process control records, and validation reports, before approving the cream production process for continued use or scaling up.
2. After approval, the process is validated and approved for commercial production.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• QbD: Quality-by-Design
• FMEA: Failure Mode Effects Analysis
• DOE: Design of Experiments

7. Documents

1. Annexure-1: QbD Documentation
2. Annexure-2: Risk Assessment Report
3. Annexure-3: Process Control Log

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
• ICH Q8 – Pharmaceutical 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: QbD Documentation

Batch Number	Identified CQAs	Critical Process Parameters (CPPs)	Risk Assessment Method	Control Strategy
12345	Texture, Consistency	Mixing Speed, Temperature	FMEA	Optimized Mixing Time

Annexure-2: Risk Assessment Report

Risk Factor	Likelihood	Impact	Mitigation Measures
Mixing speed variation	Medium	High	Regular monitoring, set parameters

Annexure-3: Process Control Log

Batch Number	Process Parameter	Recorded Value	Target Value	Deviation
12345	Mixing Speed	3000 RPM	3000 RPM	None

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