QUALITY & COMPLIANCE

High performance | Superior outcomes

Setting Global Standards in Quality, Compliance, and Trust

At Santa pharm, quality is the foundation of everything we do. As a global CDMO, we operate to the highest international standards, ensuring that every product, process, and partnership reflects our commitment to safety, efficacy, and regulatory compliance.
Our operations are fully GMP-compliant and inspected by EU authorities. We maintain a robust Quality Management System (QMS) that governs every stage of the product lifecycle—from raw material sourcing to final batch release and post-market support. Our systems are designed to ensure full traceability, data integrity, and continuous improvement.

GMP Certification

Key Quality and Compliance Highlights:

Fully certified facilities in line with EU regulatory standards.

Oversight of batch release, ensuring that every product meets defined quality specifications before reaching the market.

Audit-proven systems prepared for inspections by national and international health authorities.

All analytical methods, manufacturing procedures, and cleaning protocols are validated in accordance with ICH and pharmacopoeial requirements.

Electronic systems follow ALCOA+ principles, ensuring accurate, secure, and retrievable data.

We apply Quality Risk Management (QRM) principles throughout operations, enabling proactive decision-making and mitigation.

Ongoing training, internal audits, and CAPA systems drive excellence across teams and processes.

Our quality team works closely with clients to align on specifications, documentation, and expectations. We view compliance not just as a regulatory obligation, but as a shared commitment to product safety and patient well-being.

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