Manufacturing Validation Services
Warnex Manufacturing Validation Services, a division of Warnex Analytical Services, specializes in the validation and qualification of equipment, systems, utilities, processes, laboratory instrumentation and computerized systems for the pharmaceutical industry. Our experienced team of specialists will assist you in meeting increasing qualification and validation regulatory requirements in the global marketplace.
- Risk analysis studies
- GMP audits and training
- Validation master planning
- Design and functional requirement specifications
- Equipment/system qualifications
- Process validation
Equipment and System Qualifications
- HVAC systems and building management systems
- Utility systems: water-for-injection (WFI), purified water, clean/pure steam, compressed air systems, etc.
- Temperature-controlled equipment: autoclaves (steam sterilizers), lyophilizors, dry heat ovens, refrigerators, freezers, incubators, environmental chambers/ stability rooms, etc.
- Laboratory equipment: ovens (furnaces, muffle ovens, and vacuum ovens), refrigerators, freezers, glass washers, etc.
- Laboratory information management systems (LIMS)
- Laboratory instrumentation: UV-Vis spectrometers, FT-IR spectrometers, HPLCs, GCs, etc.
- Solid dosage products manufacturing equipment: blenders, mills, granulators, dryers, fluid bed dryers, tablet presses, tablet coaters and encapsulators
- Semi-solid products manufacturing equipment: mixing kettles, homogenizers, and mixers
- Packaging equipment: bar code verification systems, bottle unscramblers, heat sealers, inspection machines, labelers, pouch dispensers, shrink bundlers, filling machines (tablets and liquids), cappers and case packers.
- Oral solid dosage, semi-solids (ointments, creams and suspensions), as well as liquids manufacturing
- Packaging validation studies
- Cleaning validation studies