Validations

O.M.A.R. s.r.l. carries out installation and qualification of instruments in compliance with current standards and best practices in all sectors of operation. For the pharmaceutical sector in particular, we carry out installation and qualification activities, Operation Qualification, Performance Qualification (IQ/OQ/PQ) through Validation Protocols issued by manufacturers and conducted with our certified instruments and our extremely qualified technical personnel.
The Validation Protocol is drawn up according to the GMP (Good Manufacturing Practice) and GAMP 4 (Good Automated Manufacturing Practice), intended for the pharmaceutical sector.
The Validation Protocol comprises the Functional and Design Specifications of the instruments and the testing sheets needed for carrying out the tests on instruments.

IQ = INSTALLATION QUALIFICATION
The “IQ” documentation allows for the verification and testing of proper assembly of the instrumentation, correct positioning of the various components, connection to energy sources, etc.

OQ = OPERATIONAL QUALIFICATION
The “OQ” documentation allows for the verification and testing of all operations (mechanical, electronic, etc.) carried out by the instruments.

PQ = PERFORMANCE QUALIFICATION
The “PQ” documentation allows for the verification and testing of the instruments’ performance according to the technical specifications and in compliance with the reference regulations (European Pharmacopoeia, American Pharmacopoeia, GMP, GLP, etc.) in collaboration with the Customer.

The service, which entails a qualification of the installation and of the operativity of scientific and technical instruments over time, is rendered at the Customer’s facility so as to obtain and maintain conformity to the requested regulatory requirements.
At the end of the installation and qualification activities, our personnel proceed to train the Customer on ordinary use and on routine maintenance jobs of the instruments through targeted and specific training sessions.