Cleaning Validation – Sudair Pharma

Development of Cleaning Validation Master Plan and Product Matrix for Sudair Pharma

Client: Sudair Pharma
Sector: Pharmaceutical Manufacturing
Location: Kingdom of Saudi Arabia

Development of Cleaning Validation Master Plan and Product Matrix for Sudair Pharma (2)
Development of Cleaning Validation Master Plan and Product Matrix for Sudair Pharma

Background

Sudair Pharma required a comprehensive Cleaning Validation Master Plan (CVMP) to strengthen its validation program and ensure compliance with cGMP standards. The project also required establishing a scientifically sound product matrix for worst-case product identification.

Objective

To develop a robust, risk-based cleaning validation strategy that ensures effective equipment cleaning, prevents cross-contamination, and meets FDA, EMA, and PIC/S expectations.

Scope of Work

Cleaning Validation Strategy & Product Matrix Development

Preparation of the Cleaning Validation Master Plan (CVMP), defining responsibilities, methodology, acceptance criteria, and lifecycle management.
Development of a detailed product–equipment matrix to identify worst-case products based on toxicity, solubility, potency, and contact surface attributes.
Justification and rationale for product grouping and worst-case selection.
Alignment of the validation approach with the site’s production capabilities and cleaning procedures.

Challenges Identified

Broad product portfolio with diverse formulations and manufacturing lines.
Limited historical residue data and cleaning performance metrics.
Need to balance scientific rigor with operational feasibility.

Solutions Implemented

Risk-Based Validation Framework

Conducted a full risk assessment of products and manufacturing lines.
Developed a scientific, data-driven product matrix using regulatory and toxicological criteria.
Defined a validation lifecycle covering initial, periodic, and change-control-related activities.
Established clear acceptance criteria and sampling methodologies aligned with global regulatory expectations.

Results Achieved

Regulatory Alignment & Strengthened GMP Control

Successful implementation and approval of the Cleaning Validation Master Plan.
Established an effective worst-case product matrix ensuring focused and efficient validation efforts.
Enhanced audit readiness through structured, scientifically justified validation practices.
Strengthened product quality assurance and contamination control.

Conclusion

By designing a tailored CVMP and scientific product matrix, Agon enabled Sudair Pharma to build a compliant, future-ready cleaning validation program. The approach significantly improved regulatory confidence and reinforced the company’s adherence to the highest GMP standards.

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