ICH Q7 Compliance for APIs
Manufactured by Chemical Synthesis

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

Preparing for GMP Inspections

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

API in IMP - a Risk Based Approach

• IMP Regulations in ICH Q7: Chapter 19, new WHO drafts on IMPs
• What is different from Commercial Products?
• What is the necessary Degree of Formality?
• What does appropriate means practically?
• Phase-appropriateness: a practical approach to systematic Risk Management in development

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

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 testing

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

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

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