Full traceability
on all steps
of synthesis

 

SYNTH-INNOVE Laboratories well established SOP system and their up-to-date trained staff ensure total GMP compliance in Production and Quality Control.

 

A retained sample of each analysed product is kept over the API lifecycle.

Quality Assurance according to
ICH guidelines 




SYNTH-INNOVE Laboratories produces their active ingredients according to an extensive system of quality assurance which complies with international standards of GMP and ICH Q7a guideline.



SYNTH-INNOVE quality assurance system guarantees full traceability of all operations under conditions which avoid the risks of cross contamination.

Quality records are maintained available during the lifecycle of each product manufactured in our facilities.

SYNTH-INNOVE Quality Management System policies and procedures are maintained under document control. Procedures include:

  • Research and development,
  • Analytical equipment and methods,
  • Manufacturing,
  • Equipment qualification,
  • Maintenance,
  • Operations.

Our quality System includes Preventive Action procedures as Investigation and Corrective actions procedures and it is periodically updated according internal audit programs to ensure continuous improvement.

 SYNTH-INNOVE Laboratories have established a training program including Quality System and specific requirements topics.

Our manufacturing site is regularly audited in order to verify the compliance of our Quality Assurance system with Q7A on GMP for API manufacturing.

SYNTH-INNOVE Laboratories offer full cooperation to requests for Regulatory audits of our facilities.

A good knowledge of European and US guidelines allows us to anticipate regulatory changes and guarantee total compliance to GMP standards.