IMPURITY PROFILING IN PROCESS DEVELOPMENT

Four out of the top reasons for CEP rejection by the EDQM are impurity issues (EMA 2009).

Deficiencies on impurity profiles during process development are among the top then reasons for revenue losses through delayed product launch, decreased shelf life, etc.

RD&C provides support in planning, implementation, and management of impurity solutions:

Theoretical evaluation of the synthesis pathway of the drug substance and pharmaceutical development of the drug product for the prediction and probability of the emergence of certain impurities

 

Quality-by-design (QbD) approaches for process development and optimization

 

Strategies and recommendations for avoiding, analyzing and monitoring of such by- and degradation product

 

Managment of impurity analytics and structure elucidation

 

Synthesis and certification of reference material for qualification

In silico toxicologal assessment

 

Systemic impurity analysis

 

Proposal of most time-efficient and cost-saving ways to satisfy scientific, strategic, and regulatory requirements

 

Individual solutions by a standardized project management

 

Expert reports and proposal of a regulatory compliant argumentation line

Documentation of impurities for registration and variation reports.