. ICH Q7 WEEK .
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