Validation (CSV) of new pharmaceutical plant (fill and finish)

With a specialised CSV team, the validation of all systems of a complete plant is carried out. The project is divided into the following phases:
o Planning phase: URS; System Classification; CSV Plans for each system.
o Concept phase: Functional, Design and Configuration Specification (FS/DS/CS); Risk Analysis (RA); Critical Design Elements; Design Review and Qualification (DR/DQ).
o Implementation phase: FAT/SAT; start-up support; development of procedures (Disaster Recovery Plan, system administration procedure); installation and operation qualification (IQ/OQ).
o Release and delivery: ERES (Electronic Records & Electronic Signatures); ATRA (Audit Trail Risk Assessment); System description; Final commissioning and qualification reports; Final release and delivery for use.
The equipment included in the scope are:
o Core OT.
o DeltaV controlled equipment.
o Filling lines and mobile equipment.
o Clean Utilities and process support equipment.

Service engineers with extensive experience in the sector, providing an improvement in the validation execution flow and guaranteeing compliance with the requirements of the pharmaceutical industry.