Cleaning Validation Support

The manufacturing of medicinal products in shared facilities can accidentally result in cross-contamination due to uncontrolled carry-over of active substances or other starting materials. Good Manufacturing Practice (GMP) requires a “toxicological evaluation” to establish threshold values for proper risk identification during cleaning validation. SAXOCON provides you with everything you need to establish and document Permitted Daily Exposure (PDE) per regulatory requirements, including:

  • A review of available non-clinical and clinical data
  • Fill in critical data using QSAR and other in-silico models
  • Establishing PDE, based on the methods and principles in the EMA guideline for setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012)
  • Identification of significant toxic hazards such as substances with a sensitizing and/or genotoxic potential
  • Control of mutagenic impurities using the methods and principles described in ICH M7

Why choose us?

SAXOCON services for the manufacture of pharmaceutical products give you access to:

  • Extensive experience with state of the art safety assessment of pharmaceutical products according to international standards and regulatory guidelines
  • Best in class experience in using computational toxicology, including modelling of biological effects based on chemical structure
  • Smart, cost-effective test strategies that bring your products to market in a timely manner

Delivery

SAXOCON compiles a written report comprising the PDE Determination Strategy necessary for fulfilling GMP requirements.

Related Services

Nitrosamine impurities

EMA nitrosamine requirements.

Unexpected findings

Particulate matter screening.

Safe equipment

Test and secure your equipment.

Change control

Maintain GMP in relation to ICH Q7-9