Our validation approach is aligned with ISPE Good Practice Guides and EU GMP Annex 15, covering lifecycle management of facilities, utilities, and equipment. Validation establishes documented evidence that systems perform consistently within defined parameters, supporting product quality and patient safety.
Confirms that equipment and systems are installed as per design and manufacturer's requirements.
Verifies that systems operate within specified parameters under test conditions.
Demonstrates consistent performance in real operational conditions.
We develop and maintain comprehensive protocols and reports, including:
Validation Master Plans (VMP)
User Requirement Specifications (URS)
Risk Assessments (per ISPE Risk-MaPP principles)
Deviations, corrective actions, and final approval documentation
According to ISPE Baseline® Guides, validation should:
Be science- and risk-based (focus on critical aspects impacting product quality).
Incorporate Good Engineering Practice (GEP) throughout design and commissioning.
Follow a lifecycle approach, integrating design, qualification, and continued process verification.
Maintain robust Change Control & Requalification systems.
Contact our process validation experts to discuss your manufacturing process requirements. We provide comprehensive validation services to ensure regulatory compliance and product quality.