ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Date: 4 – 6 November 2019, Prague, Czech Republic

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
  
  

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
  
  

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
  
  

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)
  
  

Engineering and Equipment Design

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

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
  
  

Specific Interactive Training Sessions (please choose two sessions)

A: Defining API Starting Materials (Case Studies)
B: Cleaning Validation
C: Practical implementation of ICH Q11 - How to identify and control CQAs in API synthesis

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