ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation
30 June - 2 July 2025, Copenhagen, Denmark
Course No. 21779
Speakers
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 ChemicalSynthesis or ICH Q7 Compliance for APIs manufactured by CellCulture/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
GMP Inspections at Biotech Companies
Special considerations for inspections at Biotech Companies
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
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
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
Specific Interactive Training Sessions
Process validation for biotech manufacturing processes
Cleaning Validation
Principles of risk assessment from Cell Banks to viral safety
Compliance Session Part 3 – Life Cycle Management and Continuous Improvement
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
Drivers for Change
The regulations´ view on changes
The Importance of Change Control
Elements of a Change Control System
Roles & Responsibilities
Detailed Requirements for Specific Changes
Implementation of Changes
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
Data Integrity in the Light of ICH Q7
Which requirements are applicable to APIs under ICH Q7?
Specific Requirements and Interpretations
Consideration for specific risks
The hubris of hybrid records
Case study: how to achieve Data Integrity on a risk-based Approach
Stability Testing of APIs
Stability Specification
Stability Studies
Stability test methods
Stress tests
Packaging
Guidance on API stability testing
This course is part of the GMP Certification Programme "ECA Certified API Production Manager" Learn more
Testimonials
Seminar Programme as PDF