ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

Programme

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
Further activities

Compliance Session Part 1 – Management Process

How to use ICH Q9 and ICH Q11 in API development, manufacturing and Quality Assurance
General quality risk management process
Potential applications for quality risk management
Risk management tools suitable for manufacture of APIs
Manufacturing process development
Starting materials: selection sourcing and control
Life cycle management

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

Storage, Transport and Distribution of APIs
Flow of Materials within the Supply Chain
Batch Numbering Systems
Traceability of Starting Materials
Traceability from Dispensing to Distribution
How to Deal with Exceptions

The set-up of an efficient Quality System – How to apply ICH Q10
The Quality Unit – roles and responsibilities
21 CFR 211.22 requirements
Key principles and elements of ICH Q10
Recommendations and examples

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

Stability Testing of APIs
Stability Specification
Stability Studies
Stability test methods
Stress tests
Packaging
Guidance on API stability testing

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

Specific Interactive Training 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