Continued/Ongoing Process Verification - How to handle part 3 of the validation life cycle

13-14 June 2017

Berlin, Germany

Course No 15910

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Speakers

Timur Güvercinci, Merck KGaA, Germany

Gert Moelgaard, Head of ECA´s Validation Group, Denmark

Dr Bettina Knapp, Boehringer Ingelheim, Germany

Dr Thomas Schneppe, Bayer Pharma AG, Germany

Dr Chris Watts, VoPal, USA, Formerly with FDA

Objectives

With the Guidance for Industry “Process Validation: General Principles and Practices”, the FDA requires a new direction. Validation is now a „Life Cycle Process” with 3 stages:

Process Design
Process Qualification
Continued Process Verification

The stage 3 “Continued Process Verification” is a new step in validation. Also legacy process should be (re)validated regarding this life cycle. The start is stage 3 “Continued Process Verification”. The goal of the third validation stage is continual assurance that the process remains in a state of control (the validated state) during commercial manufacture. A system or systems for detecting unplanned departures from the process as designed is essential to accomplish this goal, says the Guidance. Now, also the EU requires Ongoing Process Verification as part of a validation lifecycle.

But how to implement Continued/Ongoing Process Verification in the routine production?
What is state of the art regarding systems for detecting unplanned departures from the process?
How to handle the monitoring at Stage 3 (Continued/Ongoing Process Verification)?
What are the differences between Continued Process Verification (FDA) and Continuous Process Verification (ICH Q8) and Ongoing Process Verification (EU)?
Are there parallels regarding Medical Devices?
What statistic parameters could help

These questions are discussed, and the possibilities for implementation are covered.

Background

Since 1987 the FDA Guideline on Process Validation has been the basis for qualification and validation. Within the new FDA programme “Pharmaceutical cGMPs for the 21st Century” there was an announcement for a revision of the guideline. A new FDA Policy Guide of 2004 gives some hints as to the new validation approach. In January 2011 the new “Guidance for Industry Process Validation: General Principles and Practices” was published as final guidance. That is now FDA’s „current thinking“. EMA´s new Process Validation Guidance also mentions a Life Cycle Approach for Process Validation. And with the citation of ICH Q8, the possibility to do Continuous Process Verification is also mentioned. In the new Annex 15 draft revision document also a Continued Process Verification, Ongoing Process Verification called, is mentioned. In the new Annex 15 revision document, valid from 1 October 2015, also a Continued Process Verification, called Ongoing Process Verification, is mentioned.

Target Group

The addressees of the event are qualified staff charged with or responsible for validation activities, especially regarding stage 3 (Continued/Ongoing Process Verification) of the process validation life cycle. We mean commissioners for validation, heads of quality assurance, department heads, etc. It also addresses members of validation teams (e.g. chemists, pharmacists, microbiologists) as well as staff who is involved in process monitoring activities and consultants.

Programme

Overview: The new process validation guides from FDA and EMA and the new industry guides from ISPE, PDA and ECA: content and principles

How the concept of Process Validation is about to change
Ongoing changes in the Quality Management philosophy
Comparision of Annex 15 revision with FDA Process Validation Guidance
Real-life examples

Parallels between Medical Device and Drug Process Validation

Leveraging experience
Quality System similarities
Standard Approaches – foundation for implementation

Case Study: From Control Strategy to Trending

Introduction in Biopharmaceutical Processes
Process development and definition of parameters
Parameters and control
Control Strategy and CPV/Trending
Case Study
Trending Report

Case Study: Large Molecules: Process Validation and Statistical Trending in Biopharmaceutical Manufacturing

Process Performance Validation Approach
Trending program and related procedures
Link to APR/PQR
Case Study

Recent trends in FDA inspections, observations and warning letters

Examples of expectations and enforcement
Regulatory enforcement trends related to observations and Warning Letters

Case Study: How to implement CPV of a legacy process

Challenges
Experiences
Lessons learnt

The bridge between the traditional and a new life cycle validation approach - the way to continuous process verification

Hybrid validation approach as a interim solution
Technology upgrade
Outlook

The future role of PAT, industrial IT and automation in continued process verification: Implementing a control strategy

Control strategy and implications for automation solutions
Bridging islands of information systems in manufacturing
From data to information to knowledge: getting gold out of data
Continued process verification: monitoring challenges
Window to the Quality: The future role of automation and IT systems in manufacturing?

Workshop Continued Process Verification – Process Data Evaluation and Conclusions
The delegates analyse in small groups process data regarding the validity of a legacy process.

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