From theory to practice: Implementing API Process Knowledge

Tuesday | 22 October


Practical assistance and experiences how to implement API Process Knowledge from a quality and regulatory perspective of:

  • Control Strategy
  • Change Control
  • Reprocessing and Rework


This Pre-Conference Session provides an overview of the regulatory and quality GMP requirements and approaches for implementing API Process Knowledge in the pharmaceutical industry. During interactive sessions you will get to know:

  • Which GMP and regulatory aspects have to be considered for establishing an adequate Change Control Management?
  • What do the guidelines tell us for reprocessing and reworking? And what are the practical consequences during the production of APIs?
  • What has to be taken into account when implementing control strategies?

Furthermore, you will have the opportunity to reach clarification on ambiguous issues by bringing your questions up for discussion.

This Pre-Conference Session ideally complements the following 27th APIC/CEFIC Global GMP & Regulatory API Conference.


The API world is changing rapidly. Nowadays, Process Knowledge is one of the most important topics in the API industry. Companies are struggling with the challenge how to implement and how to obtain Process Knowledge and ensure the quality of their products during their life cycles. On the one hand, for that matter the theoretical obligations need to be considered and well known, while on the other hand the practical implementation needs to be valuable and manageable in the daily API work.

Three hot topics out of the long list of options how to obtain and implement Process Knowledge in your company are selected and will be considered and explained during the Pre-Conference Session. Besides explaining the requirements of the guidelines of e.g. the ICH Q7 and ICH Q12 guideline for the respective themes, the speakers will share their approaches, experiences and best practices on these API related quality and regulatory topics.

Target Audience

This Pre-Conference Session is designed for all persons involved in the manufacture of APIs especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments. We are also addressing interested parties from the pharmaceutical industry and GMP inspectorates.

Control Strategy from a Quality perspective

  • Sound science & risk management all along the life cycle
  • Quality trends
  • Elements of a control strategy
  • QRM as integral part of quality by design
  • Areas of controls (hierarchy and practical examples)
  • Impact on cost of quality

Control Strategy from a Regulatory perspective

  • The control strategy in the regulatory files
  • A complete story
  • What to share with the customers

Changes from a Quality perspective

  • Different changes during product life cycle
  • Scope and importance of a change control
  • General change control requirements
  • Detailed change control requirements for specific systems (i.e. materials, process, equipment, utilities, specs & methods) with practical examples
  • Implementation requirements

Changes from a Regulatory perspective

  • Change procedures in different regions
  • Supply chain issues related to changes
  • The impact of ICH Q12

Reprocessing and rework: options and obligations

  • Definitions
  • ICH Q7 section 14.2 and ICH Q7 Q&A section 14
  • Q&A’s on practical real-life examples

Take advantage of the experiences of our speakers and send us your questions and real-life scenarios/challenges prior to the Pre-Conference Session. Your questions and examples are welcome and will be answered as comprehensively as possible by the experts during the Q&A sessions and exchange sessions.