Comprehensive pharmaceutical solutions tailored to ensure operational excellence and regulatory compliance globally.
We provide complete turnkey solutions tailored for advanced facilities aiming for highest GMP compliance. Our end-to-end expertise covers:
End-to-end GMP-compliant facility concept and detailed design tailored specifically for pharmaceutical and biopharmaceutical manufacturing. Aligned with EU GMP, US FDA and WHO, ensuring proper zoning, contamination control, and inspection readiness.
Facility layouts based on unidirectional flows for personnel, materials, and waste. We integrate regulatory expectations (Annex 1, Annex 15, WHO) directly into the layout to minimize contamination risks and ensure auditable environments.
Pharmaceutical cleanrooms meeting GMP and ISO classification. Our scope covers concept development, detailed engineering, execution coordination, full qualification, airflow management, and pressure differentials optimization.
Comprehensive HVAC system design, installation & validation. Included are critical utility systems such as PW, WFI, clean steam, and process gases optimized for robust operational compliance.
Support in defining user requirements, selecting vendors, procurement, and overseeing installation. Ensuring all equipment is fit for purpose and fully compliant with regulatory expectations from day one.
Integrate and validate systems (BMS, EMS, LIMS, QMS). We ensure data integrity, regulatory compliance with Annex 11 and 21 CFR Part 11, secure system architecture, and seamless operational integration.
Complete qualification lifecycle in accordance with best practices. From Validation Master Plan development to PQ execution, we ensure systems and processes perform as intended through a risk-based approach.
Preparing facilities and teams through technical and procedural readiness. We perform gap assessments, mock audits, documentation reviews, staff training, and on-site support to ensure successful regulatory inspections.
Process Optimization tailored to advanced biologics manufacturing and scalability.
Robust testing and validation of critical filtration systems within sterile environments.
Specialized input on transferring Biotechnology Products efficiently and compliantly.
Support for Bioequivalence (BE) studies ensuring regulatory acceptance across submissions.
Contact GPS today and discover how our expert team can assist you in achieving your goals.
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