Qualification
Bionet has a strong understanding of the regulatory particularities of the different sectors. Thereby we provide the services to adequately complement its bioprocess equipment and ensure they comply with excellence, quality, trazability and safety the authorities and customers demand.
Why qualification?
Having equipment that delivers, and a process...
…which works according to specifications, is not enough when producing in a regulated industry. The compliance with such regulatory requirements has to be demonstrated through a qualification and validation process which involves different actitivies around the following areas:
Consultation and support in the requirements definition according to the specific regulatory landscape.
Supply of the required documentary evidence.
Testing equipment and processes’ compliance with regulation and/or customer specifications.
The qualification process
To be successful the project has to be executed under QbD (Quality by Design) philosophy. That entails starting with URs (User Requirements) which are realistic, aligned with projects needs and regulatory requirements and guarantee a productive and easy to run facility. Bionet does help customers to create or review URs which comply with the above.
For DQ (Design Qualification), as the quality gate ending the engineering stages, Bionet has the methodology and experience to deliver optimized engineering design which can be easily validated.
Once construction is over and testing is there, Bionet quality team has the experience to qualify our equipment according to GMP for the production of pharmaceutical products, paving the way to your process validation.
We work in a full documented engineering environment, and we can provide our equipment with templates for DQ (Design Qualification), IQ (Installation Qualification) and OQ (Operation Qualification) tests.
These qualification services can be adapted to customer demands, from just additional documentation to complete services including FAT (Factory Acceptance Tests) and execution at customer site of SAT (Site Acceptance Tests).
