ICH Q7 Compliance for APIs
Manufactured by Chemical Synthesis
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)
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
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
- Do’s and Dont’s during inspections
Tuesday - Parallel Session
COMPLIANCE SESSION PART 2 – Production and QC Issues
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
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
Wednesday Morning - Joint Sessions
COMPLIANCE SESSION PART 3 – LIFE CYCLE 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
- Drivers for Change
- The regulations´ view on changes
- The Importance of Change Control
- Elements of a Change Control System
- Roles & Responsibilities
- Detailed Requirements for Specific Changes
- Implementation of Changes
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
Data Integrity in the Light of ICH Q7
- Which requirements are applicable to APIs under ICH Q7?
- Specific Requirements and Interpretations
- Consideration for specific risks
- The hubris of hybrid records
- Case study: how to achieve Data Integrity on a risk-based approach
Stability Testing of APIs
- Stability Specification
- Stability Studies
- Stability test methods
- Stress tests
- Packaging
- Guidance on API stability testing
