ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis - Live Online Training
ICH Q7 in modern API Manufacturing – what to do and how to do
23-25 November 2026
Course No. 22352
Speakers
Tim Ohlrich
gempex
Peter Mungenast
ehemals Merck
Dr Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting
Dr Markus Dathe
F. Hoffmann-La Roche
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
Objectives
These education courses have been developed to provide an excellent knowledge of the requirements laid down in ICH Q7. The contents of the guideline will be explained step by step and practical advices will be given on how to fulfil the requirements of ICH Q7. You will also get to know the key principles of risk management, quality systems and development and manufacture of APIs as they are laid down in ICH Q9, Q10, Q11 and the ICH Q7 Q&A Document.
For example, you will learn:
at which stage of production GMP compliance is to be applied,
how to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, change control, failure investigation etc.,
how to use a risk-based approach within the concept of supplier qualification,
how to link material attributes and process parameters to drug substances CQAs,
what has to be considered in order to be prepared for a GMP inspection.
Programme
APIC’s „How to do” Guide and further APIC Activities
ICH – A General Introduction
ICH Q7 Q&A – What to do and how to do
Regulatory Framework - an Inspector’s View
Preparing for GMP Inspections
API in IMP - a Risk Based Approach
Supply Chain Life Cycle: Reduced Testing and Supplier Qualification
Testimonials
