With the publication of the Guidance for Industry “Process Validation: General Principles and Practices” 2011, the FDA requires 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“.
The EU Process Validation Guidelines incl Annex 15 of the EU GMP requires in a similar way a 3-stage life cycle approach to Process Validation: Pharmaceutical development, Process Validation and Ongoing Process Verification. In Europe 3 validation approaches are possible – traditional, continuous and hybrid.
How can the requirements be achieved?
How 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.
Background
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.
Target Group
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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
Introduction
The validation life cycle
FDA´s current thinking
How the concept of Process Validation is about to change
Ongoing changes in the Quality Management philosophy
Real-life examples
The current EU Approach on Process Validation
Process Validation in EU guidelines
What has changed?
Revision of Chapter 1 EU GMP Guide
EMA´s Guidance Process Validation
Annex 15 revision
Excursion QbD
Excursion Legacy Products
The future of Process Validation
Process Design
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 on 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
Date of the recording: 20/21 May 2025 Duration of the recording: approx. 9 h 7 min.
This course is part of the GMP Certification Programme "ECA Certified Validation Manager" Learn more
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