ICH Q7 Compliance for APIs
Manufactured by Cell Culture/Fermentation

Monday - Joint Programme


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

ICH Q7 Q&A – What to do and how do 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

Preparing for GMP Inspections

  • Experience with GMP inspections of API manufacturers
  • Major findings/observations during inspections
  • Survey on frequently asked questions – discussion

Tuesday - Parallel Sessions


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

Specific Interactive Training Sessions (Please choose two sessions)

A. Process validation for biotech manufacturing processes
B. Cleaning Validation
C. Principles of risk assessment from Cell Banks to viral safety

Wednesday Morning - Joint Programme


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

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

Download the Programme



Download the ICH Q7 Week Programme as PDF.