ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

Date: 1 – 3 July 2019, Berlin, Germany


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

Roles and Responsibilities of the Quality Unit – How to apply ICH Q10

  • The Pharmaceutical Quality System
  • How to Apply ICH Q10 in the API area
  • The Set-up of a Good Quality System
  • Some Recommendations for the Quality Unit

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

Stability Testing of APIs

  • Stability Specification
  • Stability Studies
  • Stability test methods
  • Stress tests
  • Packaging
  • Guidance on API stability testings

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

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



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