GMP Compliance for Biopharmaceuticals AND GMP for Advanced Therapy Medicinal Products
Im Auftrag der ECA Academy

Programm

GMP Compliance for Biopharmaceuticals

GMP Requirements Applying to Biotechnological Investigational Medicinal Products (IMPs of Clinical Phases I-III & APIs for use in IMPs)

• EU regulations & guidances
• Examples of national regulations
• State-of-the-art manufacturing for clinical phases

GMP Guidelines for Biopharmaceuticals – a brief summary

• Relevant international regulations
• European biotech guidances
• Recent developments & possible impacts

Development of Biopharmaceuticals - GMP and Regulatory Aspects

• GMP and Regulatory Documents
• Ways to Success
• Interaction with Authorities (Meetings/Inspections)

Development, Qualification and Validation of Process Analytics for Biopharmaceuticals

• Relevant Guidelines
• Phases of Product Development / Testing
• Requirements
• Method Portfolio/Method Development / Method Qualification / Method Validation

GMP Inspections in Biopharmaceutical Production

• Inspections of biopharmaceutical companies
• Focus & discussion points during inspections
• Clean room classes for biotech facilities
• Open vs. closed processing
• Single - vs. multi purpose equipment
• Cell banking activities
• Inspector’s experience, examples of observations

Case Study: Process Transfer from Development to commercial Production

• Key-Aspects for EU and US
• Difference between Development and Commercial Production
• Case Study

Quality Assurance for Biopharmaceuticals

• Classical responsibilities of QA department
• Allocation of responsibilities, training of staff
• Dealing with suppliers & contractors
• The world changes: Change management
• Shit happens: Deviation management & CAPA
• Handling complaints &product recalls
• Paper, paper, paper: documentation works: SOPs, MBR, PQR & management report
• Surveillance of qualification & validation, calibration and maintenance
• Self inspections & auditing

Process Validation in Clinical Phases I-III

• Definition of Validation
• Validation in early Clinical Phase
• Validation in late Clinical Phase
• Validation Documentation
• Guidelines

State-of-the-art biotechnological manufacture (bacteria, yeast, mammalian cells) and cell banking activities - Part 1

• Reasons for cell banking
• Where does GMP start
• Characterization of cell banks
• Storage of cell banks

State-of-the-art biotechnological manufacture (bacteria, yeast, mammalian cells) and cell banking activities - Part 2

• Overview of a typical biotech process
• Requirements on production areas, raw materials
• and equipment
• Specialities on biotech products
• Fill and finish

Workshop:
Case Studies Hygienic GMP Deviations

• Examples of Pitfalls
• Chemical Interactions
• Human Errors
• Incorrect use

Prevention of cross contamination: dedicated manufacturing or cleaning validation?

• Requirements of Chapter 3 and 5 and Annex 2
• Decision with Consequences: Multipurpose
• Equipment or Disposables
• Dirt or Product: The Perspective Defines Contamination
• Ways to Remove Contaminants: Cleaning
• Procedures and their testing
• Risk Based Approach: Crucial Element of the Validation Programme

GMP for Advanced Therapy Medicinal Products (ATMP)

Tissues, Tissue Preparations and ATMPs: Introduction

• Overview on Products and Therapies: Reality and Future
• Legal Framework in EU and Germany
• CTA, Hospital Exemption and Marketing Authorisation: Steps to Consider in the Development of ATMPs

The New EU-GMP Guideline for ATMP (Part I)

• Guideline Overview
• ATMPs & Quality Risk Management
• Zone-Concept for ATMP Facility
• Focus: Qualification & Monitoring

The New EU-GMP Guideline for ATMP (Part II)

• Focus: Process-Validation & Media Fill
• Focus: Documentation
• How to certify/release an ATMP Batch
• Specific Products/Processes

GMP for ATMP – Considerations to European and US Requirements from industrial point of view

• Essential Effects of the New Guideline
• Challenges in Practice
• US Requirements

Regulatory and Practical Aspects for ATMPs - requirements for QPs

• Starting materials for ATMPs
• Raw/ancillary materials for production
• Specifics for process validation and quality control of ATMPs
• Responsibilities of the QP - what is different for ATMPs

Requirements on Manufacturing of Cell-based products under GMP

• Important Aspects for Characterisation and Control
• Quality of Reagents and Materials
• Relevant guidance documents
• Inspection Experiences and Findings
• Common Deficiencies in Clinical Trial Applications

Case Study – Manufacture of an ATMP for a phase I/II clinical trial in an academic setting

• Installation of a clean room facility for manufacture of ATMPs in an academic setting
• Establishment and validation of the manufacturing process with special focus on GMP-compliant FACS sorting
• Application for a phase I/II investigator initiated clinical trial

GMP Implementation - Practical Industrial Experiences

• Challenges in aseptic manufacturing
• Dealing with research grade raw materials in a cGMP environment
• Dealing with Contract Manufacturing organisations
• Specific cGMP challenges and possible solutions

Microbiological Safety of ATMPs

• Challenges and Critical Aspects
• Relevant Guidance Documents
• Modern Microbiological Safety Concepts
• Case Studies from Microbiological Assessment