Pharmaceutical equipment requirements
Start with the user requirement specification and the documentation your project needs.
Bring the qualification requirements forward
Share the relevant user requirement specification, product-contact requirements, cleaning strategy and required documentation. Identify the applicable project standards before requesting a quotation.
Separate equipment and facility responsibilities
- Define required material records, surface-finish criteria and inspection points.
- List requested FAT, SAT, qualification and validation support separately.
- Agree on instrument, automation and data requirements when they are in scope.
- State who approves drawings and who accepts the equipment.
Do not assume a universal certification
An equipment brochure is not a facility validation or a product-specific compliance certificate. Required evidence must match the selected configuration and purchase specification.
Every process starts
with the right questions.
Tell us what flows in, what needs to change, and what the equipment must deliver.