Speakers
Dr. Norbert Skuballa
Biologische Heilmittel Heel
All times mentioned are CET
Objectives
- How to prepare and process the data derived from validation runs of drug product manufacturing processes
- What needs to be documented about drug substance manufacturing processes
- How to manage and document post approval changes in manufacturing processes
- What to consider for compiling stability data for the dossier
- How to provide validation data of biotech manufacturing processes
Background
Guidance on process validation information to be provided in regulatory submissions is given in 2 EMA Guidelines: “Guideline on process validation for finished products – information and data to be provided in regulatory submissions” and “Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.
Provisions of both GMP compliant manufacture and dossier requirements are laid down in FDA’s Guidance for Industry entitled “Process Validation: General Principles and Practices”.
Target Group
Technical Requirements
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Programme
Seminar Programme as PDF
- Relevant guidance documents
- Finished product process validation
- Traditional and enhanced approaches
- Process validation schemes
- Standard vs. non-standard processes
- What are the opportunities and challenges?
- What are the key-aspects for the CTD?
- What should you consider for selecting the right validation strategy?
- What should you know about design space?
- What are typical validation questions to be addressed?
- Stability data from drug substances and drug products in the CTD
- Long-term and accelerated conditions, in-use stability
- Requirements for the different climatic zones
- Stability summary and conclusion
- Process parameters with potential impact on drug substance/drug product stability
- Changes in the process: what has to be considered regarding stability?
- API manufacture – What needs to be documented in the dossier?
- Process validation for APIs – Key aspects
- GMP for APIs
- Standard and non-standard processes
- Validation approach for drug substances and drug products
- Validation strategy and planning from development to registration
- Specific points to be considered for EU and US
- Approach to and considerations for process validation
- Process Design
- Process qualification and process performance qualification (PPQ)
- The PPQ protocol – execution and report
- Which GMP and regulatory aspects need to be considered (e.g. site /process changes)?
- How to define the validation strategy?
- What are the challenges?
- How to be successful?
- Process evaluation
- Critical quality attributes (CQAs) of the active subtance
- Small scale models
- Process verification studies and data
- Number of batches to be presented
- Design space option
- Evaluation of the upstream process
- Criticality assignment of process parameters
- Potential impact of raw materials
- Verification of upstream process
- Single use equipment
- Evaluation and verification of downstream process
- Comparability of products manufactured in different sites
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
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