In particular, during design phase the Functional and Design Specifications are prepared on the basis of the client URS, which, together with other design documents, are the basis for the successive qualification activities.

All the design, in particular for system that have direct impact on the customer production, like solvent recovery units for internal use, is made taking into account the matters related to the final validation phase to which the system shall be submitted after installation. In particular way the managing system and the section of the plant related to the product control before reuse are adequately configured.

At the end of the prefabrication activities, the qualification protocols are prepared (IQ, PQ). Such documents shall be checked and approved by the client QA.

Before the plant start-up all the verifications foreseen by the protocols are carried out, both for installation aspects as well as the functionality and the calibration of the elements included in the system are concerned.

In this way several units supplied by Polaris have successfully passed the validation by FDA.

For a constant update about GMP and FDA norms, Polaris is associated to ISPE (International Society for Pharmaceutical Engineering).