Methodology development
and validation

AZ Biopharm is a GLP/GMP-certified test facility

Method development and validation

The AZB develops and validates new, analytical methods which are required during product development and as well as for drug approval and registration requirements. We develop methods for:

  • Drug products
  • APIs and raw materials for the manufacture of pharmaceuticals and biotherapeutics
  • Chemically defined substances
  • Medical devices
  • Degradation products in finished formulations
  • By-products from the synthesis of active ingredients for pharmaceuticals and biotherapeutics
  • Trace components and auxiliary substances
  • Genotoxic substances
  • Extractable and leachable substances in primary packaging materials

Compliance with the applicable guidelines (EMA, FDA, ICH, VICH etc.) has top priority. Predefined validation protocols are available, making the validation process leaner, faster, and therefore more cost-effective.

We create for you:

  • Validation plans
  • Validation logs and deviation reports
  • The final validation reports
  • Method transfer protocols
  • Final test protocols

We have already been able to successfully establish/ conclude numerous methods based on our many years of experience and work out annually on average around 30 new methods for our clients.