. ICH Q7 WEEK .

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Date: 20-22 June 2022

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

Preparing for GMP Inspections, Critical Observations

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


Tuesday - Joint Programme

COMPLIANCE SESSION PART 2 – LIFE CYCLE MANAGEMENT AND CONTINUOUS IMPROVEMENT

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 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

  • ƒRegulatory 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