One of INNOTECH’s lines of business in engineering and production is validation of equipment, utilities and services systems, production areas, laboratory and process equipment at all stages, starting with Design Qualification (DQ) and all the way to Performance Qualification (PQ).
Currently, validation is a process to check for completeness, accuracy and correctness of equipment operation, conformity of the system parameters to design and GMP standard requirements. It is an integral part of creating state-of-the-art utilities and services systems for pharmaceutical plants.
INNOTECH LLC has a full range of testing equipment, instruments and tools required for qualifications, and is therefore not constrained by any challenges. All work is performed by company staff experts with good experience. INNOTECH carries out in-house qualifications along the following lines:
Design Qualification (DQ)
The preparatory stage of a production area or utilities and services design involves due diligence for design conformity to GMP, and user requirements specification – URS. The DQ stage qualifications result in a related minutes, and as data analysis is completed, a facility design qualification report is drawn up (DQ).
Installed Qualification (IQ)
The installation stage involves a checkup for completeness and correctness of equipment installation, and measuring instruments are checked for correct operation.
Operational Qualification (OQ)
The equipment operational qualification stage (OQ) involves testing the system under normal and critical load operating conditions. If a defect is revealed, the causes of the defect are analyzed and followed by rectification and re-qualification. Resultant from the Operational Qualification is full conformity of all the controlled parameters to the acceptance criteria.
Performance Qualification (PQ)
The next validation stage is to qualify the system or process line for stable operation.
The comprehensive approach to validation, qualification and certification makes it possible to achieve the European quality level for equipment, systems or production areas, as well as their conformity to all the applicable international standards.
