Method development and validation

Method development

Our laboratories develop methods to analyse the identity, strength and purity of products and raw materials, as well as developing stability indicating methods.

Our cGMP compliant facilities are equipped with state-of-the-art technology to ensure rapid and accurate product characterisation and method development. We develop:

  • High quality analytical methods that are workable throughout the life cycle of the product
  • Innovative approaches and modern instruments to achieve top precision, sensitivity and robustness
  • Troubleshooting, improvement and expansion of existing methods

Quality by Design (QbD) based analytical methods developed for degradation products using ultra-high-performance liquid chromatography (UPLC) or high-performance liquid chromatography (HPLC).

Method validation

We provide analytical validation in compliance with the European Pharmcopoeia (Ph. Eur) the US Food and Drug Administration (US FDA), current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) requirements. Our method validation service includes:

  • Method validation executed as per the current regulatory and ICH guidelines in adherence to cGMP
  • Protocols prepared by Recipharm or validation executed as per sponsor’s approved protocols
  • Custom-field calculations, e-sign off procedures
  • Meeting stringent timelines through collaborative effort with customers.