Equipment & Facility Validation
Our Equipment Qualification Program is a well developed regimen of procedures which
have been designed to ensure that your Pharmaceutical Processing Equipment is and does
what it purports to be and do. The installation of the equipment is confirmed against
exacting engineering standards and practices. Whether through comparison against
manufacturer's specifications or empirical testing of operation the equipment is
thoroughly checked for its true capabilities and repeatability.
We additionally confirm that you, as our customer, have sufficient procedures,
documentation and expertise in place to operate and maintain the equipment correctly and
consistently.
The documentation for this program is tailored to each specific piece of your equipment.
Our work is never "boiler plated". The completed binders are thorough and
contain only the information required to validate that the machines are installed
correctly and operate within a known repeatable range.
Complete Facility Qualification is documented against the building design criteria and is
also compared to accepted norms and standards for a facility which complies with Current
Good Manufacturing Practices as mandated by the USFDA. Utilities and support systems as
well as flow of product through the facility are critical factors in the qualification
process.