Considerations in Setting Specifications

28 Mar 2013

The purpose of the concept paper is to discuss considerations for setting of specifications for commercial biotech drug substances (DS) and drug products (DP) as part of an overall control strategy.
The document identifies three relevant steps:

  • Criticality assessment for product attributes.
  • Establishment of specifications as part of an overall control strategy.
  • Definition of acceptance criteria.

Recent developments in the regulatory field have focused on the application of risk-based approaches to the control of product quality based on an enhanced process and product understanding (e.g. QbD). This concept paper is applicable in a “traditional” development setting as well as in cases where such enhanced process understanding has been achieved for a particular product. It is intended that this concept paper will promote a consistent application of the existing guidance on specification setting by providing guidance based on the experience of EBE member companies.