Engineering and Validation

  • Biopharmax maintains the highest engineering standards in accordance with cGMP and in compliance with relevant regulatory authorities: Local Ministry of health, FDA and EMEA.

  • Global standards and fabrication codes are used.

  • GAMP 4 compliant

  • All our software is 21CFR11 Compliant. Biopharmax is ISO 9001:2000 and IQ NET approved
   
   

Basis of Design


Conceptual design and definition of the project including budget and time schedules

Tender
Distribution to contractors of detailed design documents, bill of quantities, etc., followed by adjudication of tenders submitted and final contract negotiations.

Construction


Site supervision of all construction work

Commissioning


Complete multi-system testing and trial running of all operations according to the pre-determined procedures. All results are documented at any given moment.

Validation


DQ - Ensuring that the design complies with the required standards.

IQ - Confirming that all equipment and instrumentation have been supplied and installed correctly as specified.

OQ -Verifying that operation of all individual pieces of equipment conform to the design specifications.

PQ - Certifying that the integrated system performs in accordance with the design criteria.

 
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