Pharmaceutical manufacturing relies on a wide range of equipment that must be qualified to ensure consistent, compliant, and robust operations. PrimeGMP provides complete lifecycle qualification for critical and non-critical equipment across sterile, non-sterile, biotech, API, and OSD facilities. Our approach ensures each system operates reliably, meets regulatory expectations, and supports strong GMP compliance.

Scope of Equipment We Qualify

1. Manufacturing Equipment

• Blenders (V-blender, Double Cone, RMG-based blenders)
• Rapid Mixer Granulators (RMG)
• Fluidized Bed Dryer (FBD)
• Tray Dryers
• Compression Machines & Capsule Filling Machines
• Coating Machines
• Planetary Mixers, Homogenizers, Stirrer Systems

2. Sterile/ Aseptic Equipment

• Laminar Airflow Units (LAFs)
• Biosafety Cabinets (BSC)
• Isolators & RABS
• Vial Washing Machines
• Filling & Sealing Machines
• Sterile Filtration Units (0.22 µm filters)

3. Cleaning & Washing Equipment

• Washing Machines (Vials, Ampoules, Garments, Parts)
• CIP / COP Systems
• Ultrasonic Washers

4. Packaging Equipment

• Blister Packing Machines
• Strip Packing Machines
• Bottle Filling & Capping Machines
• Labeling Machines

5. Utility-Connected Equipment

• Dry Heat Ovens
• Incubators
• Stability Chambers
• Refrigeration Systems
• Cold Rooms
• Warehouses (Temperature & RH Monitoring)

Qualification Services (DQ, IQ, OQ, PQ)

Design Qualification (DQ)

• Review of URS, OEM documents, P&ID
• Verification of configuration, capacity, and compliance with GMP

Installation Qualification (IQ)

• Verification of mechanical installation
• Calibration of critical instruments
• Utility connections and equipment identification

Operational Qualification (OQ)

• Operational functionality testing
• Alarm & interlock verification
• Testing at operational setpoints

Performance Qualification (PQ)

• Performance testing under actual operating conditions
• Product / process-specific challenges
• Verification of batch consistency and reproducibility

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• Calibration certificates
• Equipment logs & checklists
• SOPs for operation & maintenance
• Final qualification summary

Regulatory Standards Followed

• WHO TRS 961 / 1019
• EU GMP Annex 1 & Annex 15
• USFDA 21 CFR 210/211
• ISPE Baseline Guides
• GAMP 5 (for automated equipment)

Why Choose PrimeGMP for Equipment Qualification?

• Expertise across sterile, OSD, liquid, API, and biotech operations
• Deep technical understanding of equipment functionality
• Reliable, audit-ready documentation
• Fast execution with strong regulatory alignment
• Troubleshooting support during qualification and operation