QBD Services

By implementing a QbD strategy, a better scientific understanding is obtained and unnecessary testing is eliminated, reducing the cost and increasing the overall speed of the development process.

• To ensure desired drug product quality, safety and efficacy, a Quality Target Product Profile (QTPP) is defined prior to formulation development
• The Critical Quality Attributes (CQA) of the drug product are determined
• A risk assessment is conducted to evaluate the impact of raw material attributes and process parameters on the CQA
• A design space is established describing the relation between the input (raw material attributes and process parameters) and the end product quality.

These evaluations ensure that the manufactured drug products meet the required quality standards and remain stable throughout their shelf life.