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
GMP-conform Process Development and Validation (incl. Equipment Qualification)
- Introduction
- Current initiatives in pharmaceutical development
- Biopharmaceuticals / Biosimilars / Biological
- Process
- Analytical Methods
- Equipment / Instruments and Facility
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
Bioanalytics for Clinical Trials – Method/Process Development and Validation for Phase I – III Studies
- Definitions of terms (ICH, Q’s)
- Process development & quality by design
- Early clinical phase
- Late clinical phase
- Post approval
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
Interactive Case Studies – Deviations, Root Causes, CAPA
- 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: zhe perspective defines contamination
- Ways to remove contaminants: cleaning procedures and their testing
- Risk-based approach: Crucial element of the validation programme
Recording of 10/11 May 2022
Duration of Recording: 11 h 50 min