Quality by Design in API Manufacturing

Quality by Design in API Manufacturing

Heidelberg, Germany

Course No 16023


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Lígia Brás, Hovione, Portugal

Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Francois Vandeweyer, Janssen Pharmaceutica, Belgium

Elmar Wenzel, Freelance Consultant, Germany


During this course the principles and key aspects of Quality by Design will be discussed. You will learn

  • How to identify Critical Quality Attributes
  • How to design an effective risk based control strategy
  • How to provide QbD related information in a regulatory submission
  • How Process Analytical Technology can be applied as part of a control strategy
In an interactive workshop provides the opportunity to elaborate criticality analyses for various API syntheses.


In many cases the synthesis of small molecule APIs is achieved by using multiple intermediates which themselves are produced using different processes. To ensure the API manufacturing process consistently delivers an API meeting its specifications each of these processes needs to be robust.

The Quality by Design approach aims to scientifically determine product and process characteristics derived from criteria set after analysis of the intended drug application.

These product characteristics, the so called critical quality attributes (CQAs), must be identified and in the next step the critical process parameters (CPPs) have to be

Suitable approaches to identify these parameters are design of experiments (DOE) or general risk assessments e.g. FMEA. When linked to each other the CQAs and CPPs define the range within the process is considered to be robust.

This has to be demonstrated by a compilation of the relevant information in the application dossier.

Target Group

This course is designed for all persons which are
involved in the manufacture of APIs especially in process development, process validation, scale-up and transfer and CMC dossier preparation. Furthermore, the seminar will be of interest to personnel from quality assurance, regulatory affairs both from API and pharmaceutical companies and to contract manufacturers.


General framework and key elements of QbD for APIs – background and potential strategies

  • What is it all about?
  • What are the benefits?
  • When and how should you use it?
  • Practical examples with typical points of discussion
How to identify and control Critical Quality Attributes (CQAs) in API synthesis – a risk-based approach to developing a control strategy
  • Severity assessment of quality attributes
  • Impact levels for critical process parameters (CPPs) and critical material attributes (CMAs)
  • Considerations for the API Starting material
  • Design of an effective risk-based control strategy
  • Examples
How to provide information on the development of the API manufacturing process – dossier requirements
  • What should be done at which stage?
  • Which information is relevant for the dossier?
  • What are the key-points to be considered for APIs (NCE/Biotech) and their formulations
  • Typical questions from Authorities
Process Evaluation and Design Space
  • Changing Validation Approach
  • Validation Life Cycle
  • Design Space Concept
Application of PAT in the API industry
  • PAT at development stages of a QbD-based development
  • PAT as part of the Control Strategy in a GMP environment
  • Practical examples of PAT implementations at a commercial scale in a GMP environmen
Control strategies – Case studies and examples
  • HA definitions
  • Why and When is a control strategy needed
  • Different types/elements of a control strategy
  • Practical examples
Workshop Identification and classification of CQAs in API synthesis
In this workshop delegates will elaborate criticality analyses of different APIs. As part of this analyses critical quality attributes and critical process steps within the synthesis of the APIs will be identified.

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