Equipment Validation
We have pharmaceutical validation experience with the following type of manufacturing lines and associated equipment:

Filling Lines:
Unscramblers, Sterile/Non-Sterile Fillers, Vial/Bottle Washers, LATs (Loading Accumulation Tables), UATs (Unloading Accumulation Tables), Freeze Dryers, Cappers and Neckbanders.

Packaging Lines:
Labelers, Cartoners, Casepackers, Palletizers, Conveyors and Product Transport Equipment.

Documentation
We have experience within FDA regulated environments and act in accordance with cGMPs (Current Good Manufacturing Practices).

We remain current and in compliance with the following federal regulations:
• cGMPs (21CFR Part 210 and 211)
• Electronic Records and Signatures (21 CFR Part 11)
• Quality System Regulations (21 CFR Part 820)

We can create documentation with ensuing protocol execution.
• User Requirements
• Functional Specifications
• Design Documents
• Flow Charts
• Sequencing Spreadsheets
• FATs (Factory Acceptance Tests)
• IQ (Installation Qualification)
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• Disaster Recovery Procedures
• Operating Procedures (SOPs, PMs)