ICH Q7 Compliance for APIs
Manufactured by Cell Culture/Fermentation


Monday - Joint Programme


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)

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

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


COMPLIANCE SESSION PART 2 – PRODUCTION AND QC ISSUES

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


Wednesday Morning - Joint Programme


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

  • 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
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