ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

01-03 July 2019, Berlin, Germany

Course No. 17201



Gempex, Germany
Roche Diagnostics, Germany
Merck KGaA, Germany
Roche Diagnostics, Germany
Philips Image Guided Therapies, The Netherlands
Biopharm Consulting, UK
Janssen Pharmaceutica, Belgium
Aspen Oss B.V.
Iskom, Germany


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 and Q11. 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.

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, the Training Course will provide 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 education 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 and control, technical and regulatory affairs departments as well as for Qualified Persons and Auditors of the Manufacturing Authorisation Holders. We are also addressing interested parties from engineering companies, from the pharmaceutical industry and GMP inspectorates


Regulatory Session

ICH Q7 - A Regulatory Introduction
General overview of Regulations (EU, US and others)
Introduction of ICH
ICH Q7 in general
ICH Q7 for chemical APIs / for biotech APIs
The new ICH Q7 Q&A Document

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
Further activities

Compliance Session Part 1 – Management Process

How to use ICH Q9 and ICH Q11 in API development, manufacturing and Quality Assurance
General quality risk management process
Potential applications for quality risk management
Risk management tools suitable for manufacture of APIs
Manufacturing process development
Starting materials: selection sourcing and control
Life cycle management

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

Storage, Transport and Distribution of APIs
Flow of Materials within the Supply Chain
Batch Numbering Systems
Traceability of Starting Materials
Traceability from Dispensing to Distribution
How to Deal with Exceptions

The set-up of an efficient Quality System – How to apply ICH Q10
The Quality Unit – roles and responsibilities
21 CFR 211.22 requirements
Key principles and elements of ICH Q10
Recommendations and examples

Compliance Session Part 2 – Production and QC Issues

Cleaning Validation
Cleaning requirements and cleaning methods
Cleaning verification versus validation
Acceptance levels
Cleaning validation approaches in mono vs multipurpose environments
Monitoring of cleaning effectiveness after validation

Stability Testing of APIs
Stability Specification
Stability Studies
Stability test methods
Stress tests
Guidance on API stability testing

Equipment Qualification and Calibration
Regulatory requirements – guidelines
Validation project: Validation Master Plan – risk analysis, DQ, IQ, OQ, PQ
Practical approaches to equipment qualification and calibration
How to handle “old equipment”
Documentation (validation plans and protocols, validation report, revalidation)

Process Validation in API manufacturing
Regulatory requirements in the EU and US
Key principles of the FDA Guidance on Process Validation
Validation approaches and how to apply the principles of ICH Q8, Q9, Q10 and Q11
Continuous process verification and life-cycle approach

Engineering and Equipment Design
Good Engineering Practices
Buildings, equipment
Flow of materials
Requirements for utilities
Water quality in API manufacture

Specific Interactive Training Sessions
A: Defining API Starting Materials (Case Studies)
B: Cleaning Validation
C: Practical implementation of ICH Q11 – How to identify and control CQAs in API synthesis

Compliance Session Part 3 – Lifecycle 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
Changes: Good or bad? Forced or voluntary?
The importance of Change Control
Scope and responsibilities
General requirements
Detailed requirements for Specific Changes
Implementation of Changes

Deviation Handling and Failure Investigations
Definitions and Basic Requirements
Scope and Responsibilities
Detailed Requirements
Principles of Justification for Deviations
A quick look on Root Cause Analysis
The Role of the Quality Unit for Handling Deviations and Justification

Preparing for GMP Inspections, Critical Observations
Experience with GMP inspections of API manufacturers
Major findings/observations during inspections
Survey on frequently asked questions – discussion of their relevance


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

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

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