Drug Substances & Products Manufacturing
Safe equipment and systems
SAXOCON can help you ensure that any production equipment that comes into contact with drug substances or drug products is documented to be in compliance with regulatory requirements for pharmaceutical manufacturing systems.
Pharma manufacturing change control
SAXOCON provides services that let you understand the impact of changes, deviations or non-conformance in relation to ICH Q7, Q8, and Q9. Maintain Good Manufacturing Practice (GMP) and proper risk management of product quality.
Cleaning validation support
SAXOCON helps you to establish and document Permitted Daily Exposure (PDE) in accordance with regulatory requirements for the manufacture of medicinal products in shared facilities. Thus helping to establish threshold values for proper risk identification during cleaning validation.
Unexpected particulate matter findings
With a SAXOCON service level agreement (SLA), you will have everything you need to analyse and evaluate the impact of deviations or non-conformances when sudden unexpected findings of particulate matter in, or in contact with, your drug products appear.