The PURELAB® Pharma Compliance
The PURELAB® Pharma Compliance offers all the necessary purification features, software capabilities, qualification documentation and services required to meet GMP. Building the perfect relationship between discovery, production and traceability, resulting in an intuitive, efficient and compliant purification system.
Quality management system
ELGA Labwater is a subsidiary of the Veolia group, whose Quality Management System is approved by Lloyd’s Register Quality Assurance (LRQA) and CISO 9001.
Global service support
To support clients’ performance qualification (PQ) procedures ELGA and the Veolia service teams manage annual servicing and calibration with minimised disruption.
The PURELAB Pharma Compliance delivers the water to support the QC test necessary to validate drug purity in pharma manufacturing. Consumables are designed to minimise cost and waste.
Components have been proven in thousands of water systems globally, and result from over a decade of user experience and feedback. ELGA’s quality systems ensure that volume manufacturing sites with high frequency batch sampling and mandatory quality control function without unplanned interventions.
Digital record keeping
The PURELAB Pharma Compliance’s admin functions, security and data integrity capabilities, password accessibility, audit trail procedures and permissions all meet national regulators best practice for data management in QC labs following GMP standards.
Installation qualification (IQ) and operational qualification (OQ) documents are supplied as part of ELGA’s standard offerings.
United States Pharmacopeia (USP) Standards
Purification and servicing processes support the total organic carbon (TOC) measurement and water conductivity measurement required by USP 643 and 645.
Designed to comply
Designed to meet FDA, USP, EUDRALEX, European Pharmacopeia and all GMP requirements for Quality Control laboratories.