24/25 April 2023
Dr Line Lundsberg-Nielsen, Lundsberg Consulting Ltd., U.K.
With the publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:
- Process Design
- Process Qualification
- Continued Process Verification
The focus is on process knowledge and process understanding. Both should be a result of development and verified in routine production. The “magic” 3 batches are not mentioned any more. What is very important nowadays is the term „scientific sound“, and explicit statistics are mentioned. Six Sigma elements (e.g. Design of Experiments, DoE) are also mentioned directly or indirectly. There is also a stage in routine production called „continued process verification“.
With the revision of Annex 15 EU GMP Guide in 2015 the EU is going in the same direction: Validation is a lifecycle with pharmaceutical development as basis and also a stage 3 is mentioned, called Ongoing Process Verification. In Europe 3 validation approaches are now possible – traditional, continuous and hybrid.
- How can the requirements be achieved?
- How to fit the FDA requirements into European guidelines and vice versa?
- How can process knowledge and process understanding be demonstrated on the basis of development studies?
- When is a process valid now?
- Which parameters can be used for knowledge and understanding studies?
- How can „continued/ongoing process verification” be realised?
These questions are at the centre of this online-course.
Since 1987, the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A FDA Policy Guide of 2004 gave some hints to the new validation approach. In November 2008 the “Guidance for Industry Process Validation: General Principles and Practices” was published as a draft and came into operation in January 2011. That is now FDA’s „current thinking“. The chapter 1 of the EU GMP Guide gives hints for more emphasises on process capabilities and varieties within process validation also in Europe. EMA´s Process Validation Guidance and also the revised Annex 15 from 2015 takes a life cycle approach to process validation nowadays.
The addressees of the event are qualified staff charged with or responsible for validation activities, such as commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. engineers, chemists, pharmacists, microbiologists) as well as representatives of the plant engineering industry and consultants.
- The validation life cycle
Process Validation Life Cycle, Regulatory Requirements
- Setting the scene for Process Validation
- Introduction to EMA’s PV guides, Annex 15, and to FDA’s PV guide
- Regulatory requirements
- Process Design
- Quality by Design, ICH Q8 and Q11
- Quality Target Product Profile
- Critical Quality Attribute
- Critical Process Parameter
- Design Space
- Control Strategy
- Continual Improvement
- Link between QbD the Control Strategy and Process Design
Systems and Tools for gaining Process
- Understanding and establishing the Control Strategy
- Process Understanding & the Control Strategy
- Quality Risk Management
- Process Analytical Technology
- Design of Experiments
- Process Analysers
- Multivariate Data Analysis
Case Study Process Design
- Stage 1
- Applying QbD principles to design a process for an oral solid dosage formulation
- Examples of the application of DoE and PAT
- Establishing the control strategy
Process Validation / Process Performance Qualification
- The purpose and principles of PV/PPQ
- EU’s different approaches to Process Validation
- Number of PV/PPQ batches
- Acceptance criteria
- PV/PPQ readiness
- PV/PPQ reporting and conclusion
Case Study Process Validation / Process Performance Qualification
- Stage 2.1: Designing the equipment and facility qualification programme based on the control strategy
- Stage 2.2: Establishing the PPQ/PV programme based oin the control strategy
- Justifying the number of PPQ/PV batches
- Presenting and evaluating data
- Concluding the PPQ/PV activities
- Proposing a stage 3 CPV/OPV programme
Ongoing/Continued Process Verification
- EMA: Ongoing Process Verification
- FDA: Continued Process Verification
- Statistical tools
- Monitoring plan – OPV/CPV plan
- OPV/CPV for legacy products
Case Study Ongoing/Continued Process Verification
- Establishing the CPV/OPV programme
- Application of relevant statistics during stage 3
Case Study Ongoing Process Verification Programme for Legacy Products
- Establishing an OPV programme for legacy products
- Defining the relevant statistical metrics
- Running, evaluating and updating the programme
Wrap-up and considerations for Process Validation in a future Industry 4.0 manufacturing environment
- How will process validation evolve in light of more automated and self-optimising processes
- A holistic approach to validation – covering qualification of equipment, control systems, computer systems, processes and analytical technologies and methods
- The role of the control strategy
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