GMP Equipment Documentation Package
Installation qualification is a documentation package that ensures receipt and proper installation of the appropriate parts and systems of the Process Equipment. Many years of direct experience has allowed United Science to assemble this comprehensive set of detailed documents that may be used as templates to assist those who desire to have GMP compliance on specified equipment. Included in this package are hundreds of pages of valuable documents and easy to use templates that will assist you in meeting cGMP and/or euGMP requirements associated with audits and inspection.
Documentation Includes Material Certifications for All
- Wetted Surfaces
- Certified Gauges
- Calibration Certifications for all Extractor Quality Processes
Whether you are building from scratch or retrofitting an existing building to meet your manufacturing and packaging needs, our expert designers will help you develop your ideal botanical extraction lab.
Deliverables Included
- Componente Cut Sheets
- Required Utilities for Equipment Operation
- Installation Drawings
- Manufacturer Generated URS
- Control Panel Logic
- Top Level P&ID
- Top Level Assembly Drawings
- Alarms with Limits & Default Settings
Lists & Manuals
- Packing List
- Operation & Maintenance Manuals
- Critical Spare Parts List
- Equipment Instrument List
Additional Terms
- Additional requested items will be charged to the customer at $2K USD per item.
- All documentation is supplied in PDF format and is United Science confidential for one time use for the specified equipment.
- When applicable, buy component manuals will be provided to the customer. ?
- c/euGMP certification package must be specified prior to equipment purchase.
- This GMP package has no implied or express warranty or guarantee of compliance with local, federal, or international regulations.
Certificates
- Product Contact Surface Material Certificates
- Instrument Calibration Certificates
Schematics
- Equipment & Electrical Point to Point
- Electrical Panel
- Control & PLC Logic
Get in touch with our team to request a quote, learn more about our training or get help with your business plan.
We are dedicated to providing you with the best advice, quality and service in the industry.
