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EU-GMP (Europe) and TGA GMP (Australia) Compliance Services
Achieve full compliance with international Good Manufacturing Practice standards
- Global GMP Standards
Support for EU GMP (Europe) and TGA GMP (Australia) compliance.
- Facility and Process Advisory
Guidance on floorplan design, air flow and ventilation, personnel flow, process flow, product and waste flow to meet stringent GMP requirements.
- GMP Documentation Development
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- • Preparation of necessary documents, including:
- • Validation Master Plan (VMP)
- • Site Master File (SMF)
- • User Requirement Specification (URS) and Design Qualification (DQ)
- • IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) and report writing.
- • Cleaning and Process Validation Protocols
- • Stability Program Protocol
- GMP Documentation Development
Comprehensive virtual or on-site audits to evaluate GMP readiness.