ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
30 June - 2 July 2025, Copenhagen, Denmark
Course No. 21778
Speakers
Tim Ohlrich
gempex
Peter Mungenast
Formerly Merck
Francois Vandeweyer
VDWcGMP Consulting
Dr Markus Dathe
F. Hoffmann-La Roche
Dr Frank Sielaff
Hessisches Landesamt für Gesundheit und Pflege
Dr Thomas Becker
Dr. Thomas Becker Pharma & Biotech Consulting
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 fulfill 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.
Choose between two parallel GMP education courses according to your field of interest:
ICH Q7 Compliance for APIs manufactured by Chemical Synthesis or ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation
Take advantage of combining one of the ICH Q7 Courses with the Auditor Training Course and receive the ECA Certifcate “QA Manager and Auditor for APIs”.
The ICH Q7 Auditor Training Course will inform you about the general advice on Good Auditing Practices included in the APIC “Auditing Guide” and the APIC Third Party Audit Programme. In addition to the training of the communication skills, you will be provided with assistance on what to focus on during an API audit and on the current “state of the art” from an industry perspective. Moreover, you will learn about the key principles of writing a professional audit report.
Target Group
These training courses are designed for all persons involved in the manufacture of APIs (either chemically or by cell culture/fermentation), especially for persons from production, quality control, quality assurance, technical and regulatory affairs departments as well as for Qualified Persons and Auditors. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates.
APIC’s „How to do” Guide and further APIC Activities
Information on APIC
Contribution to GMP Compliance and Supply Chain Integrity - How to do Document ´- Quality Agreements - ASMF Guideline - FMD and GDP for APIs
ICH Q7 Q&A How to do Document
Further activities
ICH – A General Introduction
What is ICH ?
API related ICH Guidelines
ICH Quality Guidelines
ICH Q7 – Hot topics and requirements
Overview of guidance documents (Q8 to Q14)
ICH Q7 Q&A – What to do and how to do
Overview about the ICH Q7 Questions and Answers Document
Some Highlights from the Q&A Document and their Interpretation - Distribution procedures, intercontinental shipments - Risk assessment and Validation - Complaints and recalls
Interactive Session
Regulatory Framework - an Inspector’s View
Overview: relevant guidelines
Inspections in drug product facilities - relevant topics for API manufacturers
Recent findings in inspections
Preparing for GMP Inspections
Experience with GMP inspections of API manufacturers
Major findings/observations during inspections
Do’s and Dont’s during inspections
Major Compliance Issues at API Manufacturers
Common pitfalls and typical audit findings
Top observations from inspections by European authorities
Experiences made by FDA
Recent statistics from FDA Warning Letters to API manufacturers
Compliance Session Part 2 – Production and QC Issues
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Testimonials
Seminar Programme as PDF