Credentials

Pharmaceutical manufacturing credentials and accreditation

GMPLEX™ operates to Australian TGA expectations and PIC/S PE009, with an independent quality unit and full batch-release control. Download the summaries below, or request the controlled pack under confidentiality.

TGAAustralia

TGA Accreditation

Australian manufacturing licence scope, inspection history and ARTG registration support.

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GMPGlobal

GMP Quality System

Quality management system, analytical capability and independent batch release.

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PIC/SGlobal

PIC/S Compliance

PE009 alignment, data integrity controls and partner audit readiness pack.

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Brochures are provided for information only. Controlled, signed and site-specific documentation is issued on request under confidentiality.