. ICH Q7 WEEK .

ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Date: 11 – 13 June, Copenhagen, Denmark

REGULATORY SESSION

ICH Q7 - A Regulatory Introduction

  • General overview of Regulations (EU, US and others)
  • Introduction of ICH
  • ICH Q7 in General
  • ICH Q7 for chemical APIs / for biotech APIs
  • The new ICH Q7 Q&A Document

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

COMPLIANCE SESSION PART 1 – MANAGEMENT PROCESS

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

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

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

Stability Testing of APIs

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

 

COMPLIANCE SESSION PART 2 – PRODUCTION AND QC ISSUES

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


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 report, revalidation)


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

Engineering and Equipment Design

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

COMPLIANCE SESSION PART 3 – LIFECYCLE 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

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