ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation - Live Online Training

18-20 November 2024

Course No. 21208



Francois Vandeweyer

Francois Vandeweyer

VDWcGMP Consulting

Dr. Markus Dathe

Dr. Markus Dathe

F. Hoffmann-La Roche

Dr. Frank Sielaff

Dr. Frank Sielaff

Hessisches Landesamt für Gesundheit und Pflege

Dr. Thomas Becker

Dr. Thomas Becker

Dr. Thomas Becker Pharma & Biotech Consulting

All times mentioned are CET


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.
Choose between two parallel GMP education courses according to your field of interest:
  • ICH Q7 Compliance for APIs manufactured by Chemical Synthesis
  • 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.
As the number of participants for the Auditor Training Course is strictly limited early booking is recommended!

Target Group

These Live Online 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.

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Participants intending to obtain the APIC Auditor Certification: The Role Plays are mandatory for all participants intending to obtain the APIC Auditor Certification. Due to this fact, please make sure that you will have a webcam, microphone (preferably headset), a constant internet connection (preferably via LAN) and join the Webex session via the Webex Application (not via the temporarily browser application). Please note that during the Role Plays other participants will be able to view your chosen name, see your picture and hear your voice.


ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation - Live Online Training

Seminar Programme as PDF

Compliance Session Part 1 – Management Process
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)
Regulatory Framework - an Inspector’s view
  • Overview: relevant Guidelines
  • Inspections in drug product facilities - relevant topics for API manufacturers
  • Recent findings in 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
Preparing for GMP Inspections, Critical Observations
  • Experience with GMP inspections of API manufacturers
  • Major findings/observations during inspections
  • Survey on frequently asked questions – discussion
Compliance Session Part 2 – Life cycle management and continuous improvement

API in IMP - a Risk Based Approach

  •  IMP Regulations in ICH Q7: Chapter 19, new WHO drafts on IMPs
  •  What is different from Commercial Products?
  •  What is the necessary Degree of Formality?
  •  What does appropriate means practically?
  •  Phase-appropriateness: a practical approach to systematic Risk Management in development

Supply Chain Life Cycle: Reduced Testing and Supplier Qualification

  •  ICH Q7 requirements
  •  Supplier qualification covering the full supply Chain
  •  One strategy for supplier qualification from non-critical raw material to API
  •  Requirements and strategy for reduced testing (CoA release) of materials

Internal Change Control Management

  • Changes: Good or bad? Forced or voluntary?
  • The importance of Change Control
  • Scope and general requirements
  • Detailed requirements for specific Changes
  • Implementation of Changes

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
    • Compliants and recalls
  • Interactive Sessions

Stability Testing of APIs

  •  Stability Specification
  •  Stability Studies
  •  Stability test Methods
  •  Stress Tests
  • Packaging
  • Guidance on API stability testing

How to implement ICH Q3D

  • Regulatory requirements
  • „Five steps implementation strategy“
  • How to handle CEP updates and new registrations from
    the perspective of the Marketing Authorisation Holder

GMP Inspections at Biotech Companies

  •  General inspection principles
  •  Cell Banks Facility
  •  Biological Materials and Culture Media
  •  Fermentation
  •  Viral removal/inactivation
  •  Laboratories
  •  Recent regulatory findings
  •  Most common FDA audit observations

Instances of Virus Contamination in GMP
manufactured Products – what can we learn?

  • Virus contamination in GMP manufactured products (examples)
  • How to implement continued vigilance with regard to potential virus contamination
  • Virus contamination and root cause Analysis
  • Application of appropriate risk control measures 
  • Approaches to minimise the risk of contamination

Cellbanking –Master Cell Banks (MCB) and Working Cell Banks (WCB)

  • Establishment of MCB and WCB
  • Definition of ’API starting material’
  • Cell Bank qualification and testing
  • Cell Bank maintenance and record keeping

Cleaning and Cleaning Validation in Biotech
Manufacturing Processes

  • Identification of cleaning mechanisms and selection
  • of cleaning agents
  • Selection of analytical methods for the detection of
  • residues
  • Establishment of limits in fermentation and Downstream
  • processing
  • Grouping strategies
  • Final rinse versus swab testing



This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more

ECA-Member*: € 1790,-
Non ECA Member*: € 1990,-
EU/GMP Inspectorates*: € 995,-
APIC Member Discount*: € 1890,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
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Further dates online
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Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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