MN Validation Solutions Pty Ltd

We offer Validation, Compliance and Quality Assurance consultancy services to Pharmaceutical and Medical manufacturers. Our services include but are not limited to the following: - Manufacturing Facility Design (Sterile, Non-sterile and Medicinal Cannabis - GACP, GMP, EU GMP) - Gap Analysis - Assistance is setting up new pharmaceutical manufacturing facilities i.e Sterile, Non-sterile, GACP (medicinal cannabis), GMP (medicinal cannabis). - Facility (Area or Room) Qualification. - Qualification of Utilities (Purified Water, Water for Injection, Pure Steam, HVAC, Nitrogen and Compressed air). - Equipment Qualification (Manufacturing, Packaging and Laboratory) - Cleaning Validation - Process Validation and optimisation - Packaging Validation - Computer Systems Validation - Quality Assurance: Quality Management System design, Site Master File compilation, Standard Operating Procedures (SOP) compilation, Quality Risk Assessments compilation, Regulatory Audit preparation support, Training, Quality Manual compilation, Vendor evaluations and Technical Quality Agreements compilation. - Site Maintenance Plans and Service Level Agreements (SLA) preparation. - Management Consulting for your specific business and supply chain objectives - Cold Chain temperature mapping services: Cryo-freezers, Freezers, Freeze Driers, Fridges. - Thermal validation/ mapping services: Steam Sterilisers, Incubators, Dry heat sterilisers, Water Cascade/ Fall sterilisers, Depylrogenation Ovens, Tunnels and Vacuum Ovens. - Environmental temperature and humidity monitoring: Warehouses, Cold Rooms and Stability Chambers.