FDA Validation
BWIR has been working in the FDA Pharma environment in the U.S. since the year 2001. In excess of 20,000 hours of consulting experience with major Pharma companies, BWIR's capabilities encompass master plan preparation, UFRS/ FAT/COM IQ/OQ/PQ protocol development/execution for a wide range of equipment, processes, computer and automated systems.
We have serviced the following clients in association with our Group Company, Design Group.
- Schering-Plough
- Wyeth
- Novartis
- Pfizer
- Fuji
- Sanofi Aventis etc.
Equipment Validation
Experience includes validation of the following equipment under cGMP guidelines:
- Packaging - Blister Lines, Bottle Lines
- Liquid Fill Lines
- Aerosol Lines
- Dry Powder Inhaler Line
- Chapstick Line
Other equipment include Fillers, Spray Testers, Checkweighers, Microfluidizer, Homogenizer, Capper, Retorquer, Thermoformers, Wallet Machine, Cartoners, Dosage Cup placers, Labelers, Sealers, Casepackers, and Palletizers.
Computer System Validation and Process Validation
BWIR develops, executes, and summarizes all SDLC documentation utilizing a GAMP methodology and compliant with client SOPs, and 21 CFR Part 11.
Complete documentation is provided that includes User Requirement Specifications, Functional Specifications, Hardware/Software Design Specifications, Unit and Modular Testing, Commissioning, and IQ/OQ/PQ protocols for computer systems used in pharmaceutical, biotechnology and medical device manufacturing.
Systems range from plant floor level controllers (PLC's), middleware (SCADA/DCS), through enterprise planning systems (ERP/SAP).
The Process/CSV projects include:
- Computer System and Process Validation services to support a new Radiological Medical Device facility start-up
- Validated systems include DCS, FCS, MES, and other indigenously developed automated systems.
- Computer Validation services to support a new bottling line facility start-up. Process Scope included Central Palletizing SCADA system,
- Computer Validation services including developing Validation Master Plan and implementing SCADA systems on 3 packaging lines.