Quality Compliance

Zdravlje’s Quality Compliance encompasses Quality Assurance (QA), Qualified Person (QP) roles, advanced Physicochemical and Microbiological laboratories, and comprehensive Quality Systems services.

QA & QP

We maintain a high level of quality by ensuring product efficacy and safety. Product Quality Reviews are prepared for Marketing Authorization Holders in compliance with regulatory requirements, utilizing statistical methodologies that cover Critical Quality Attributes, Process Capability, and Continuous Process Verification.

GMP Compliance & Quality Systems

Our experienced and qualified personnel ensure supplier and contractor compliance through a robust auditing management system that includes planning, performance monitoring, Corrective and Preventive Actions (CAPA) follow-up, and effectiveness assessments.

Laboratories

By implementing science-based methodologies, sophisticated equipment, and qualified personnel, our laboratories perform all necessary testing for:

• Excipients and Active Pharmaceutical Ingredients (APIs)

• Analytical Method Transfer

• Stability Studies

• Bulk Products

• Manufacturing & Packaging