Qualification of your systems and equipment is
an integral part of the validation process.
Qualification of systems and equipment is part of the process of validation. Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance.
The ISPE Good Practice Guide and Applied Risk Management for Commissioning and Qualification go through to the Equipment qualification to perform IQ (for verification of design specification), OQ (for functional specifications) and PQ (to meet requirements).
Cannabis Compliance Inc.’s validation team performs Equipment qualification by applying the appropriate tool to Client’s related systems, for example Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) among others, as follows:
- Factory Acceptance Test (FAT), the documented evidence that a piece of equipment or system has been adequately tested at the manufacturer’s facility and performed to the end user’s expectations prior to delivery to the end user, or
- Site Acceptance Test (SAT)- documented evidence that a piece of equipment or system has not been affected in the transportation and has been adequately tested at the end user’s facility and performed to end user’s expectation.