ICH Q7 Compliance for APIs
Manufactured by Chemical Synthesis

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

Preparing for GMP Inspections

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

Tuesday - Joint Programme


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 general requirements
  • Detailed requirements for specific Changes
  • Implementation of Changes

ICH Q7 Q&A – What to do and how to 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

Wednesday Morning - Parallel Sessions

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

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 reports, revalidation)

Engineering and Equipment Design

  • Good Engineering Practices
  • Buildings, equipment
  • Flow of materials
  • Requirements for utilities
  • Water quality in API manufacture
  • Containment

Download the Programme



Download the ICH Q7 Week Programme as PDF.