national validation forum iii · slide 2 © pharmout 2014 welcome •confidentiality –chatham...
TRANSCRIPT
National Validation Forum III
Presented by Trevor Schoerie
12 May, 2014
Slide 2 © PharmOut 2014
Welcome
• Confidentiality – Chatham House • Please contribute • Please network• Please relax and enjoy yourself
Please put your phone, smartphone, Phablet and / or tablet on silent
Slide 3 © PharmOut 2014
Why are we here?
• Boss sent me• Want to learn the latest• Want sometime practical take backs• Want to contribute to shaping regulations
• Want practical, value adding validation
Slide 4 © PharmOut 2014
How we got here and where next?
Recap of NVF I and NVF II (TGA co-presented)
Draft EU Annex 15 - Qualification & Validation
Statistics
Risk or Criticality
Future Trends
Questions & Answers Session
Slide 5 © PharmOut 2014
National Validation Forum I - 2011
|1987 | 2000 |2002 | 2004 | 2006 | 2008 2010 | 2011 2014
FDA Guide to Process Validation
EU Annex
15
FDA: Pharmaceutical cGMPs For The
21st Century
ICH Q9
FDA: Quality System
Approach to Pharmaceutical
cGMP
PICSVMP
ISPE C&Q Baseline 5
Guide
ISPE 21st
Century Qualification White Paper
ICH Q8
ASTM E2500-
07
FDA Process
Val. Guidance
EMAProcess
Val
ASTM E2500-
07
ICH Q10
ICH Q11
National Validation Forum II Jun 2012
National Validation Forum I
Dec 2011
Slide 6 © PharmOut 2014
National Validation Forum I - 2011
• Consistent National Validation approach
• Develop a framework like GAMP® 5
• Each industry sector to have its own guides
• Start of a journey: want practical, value adding validation
“To develop a risk-based scalable approach to the qualification of facilities, systems and equipment
(FSE) by categorizing medicinal product types based on risk, and scaling the qualification effort required
based on the developed categorization”
Slide 7 © PharmOut 2014
National Validation Forum I - 2011Top Gear – Cool Wall
Sun cream Products
Oral Solid Dose
Products
Blood & Tissue
Parenteral Products
RISK
Product Category Examples
Validation Effort
Slide 8 © PharmOut 2014
National Validation Forum I - 2011
The Risk “Cool Wall”
Slide 9 © PharmOut 2014
National Validation Forum I - 2011
S
O
P
Product Category Examples
Validation Effort
Not always possible due to FSE and
process complexity & novelty
Category 1 Category 5
Slide 10 © PharmOut 2014
National Validation Forum I - 2011
The issues discussed:
• Perceived industry problems: From QTPP, CQA, CPP, Control Strategy, Risk Assessment, Process Validation
• Paradigm shifts – Process Validation based on QbD, Design Space, etc.
• Incremental changes:
• “Plain vanilla” validation – Annex 15
• Integrated C&Q – ISPE Baseline
• ASTM E2500
• Design Qualification vs Review
Slide 11 © PharmOut 2014
National Validation Forum I - 2011
Outcomes:
• The effective use of Design Review-“fit for use”
• Using a science-based approach along with QRM tools for the development of a Control Strategy to concentrate qualification tasks on the critical aspects
• The use of qualified vendors with a suitable QMS and leveraging during qualification
• The need for Subject Matter Experts
• An effective Quality Management System
Science &
Risk
Slide 12 © PharmOut 2014
National Validation Forum II - 2012
The approach:
• Developed Case Studies from the categories created in NVF I (Sterile and non-sterile)
• From an example QTPP, developed CQA’s, CPPs, and using QRM, developed a Control Strategy
• Using the information obtained to assist in planning and prioritising Qualification & Validation
• US FDA Process Validation Guide
• EU Draft Guide on PV
Slide 13 © PharmOut 2014
National Validation Forum II - 2012
Define the Quality Target Product Profile
(QTPP)
Identify the CQAs
Define Process Steps & CPPs
Create a Control Strategy
Stage 1
Implement the Control Strategy
Qualify Facility, Utilities,
Systems and Equipment
Process Validation
(PPQ)
ContinuedProcess
Verification
Stage 2
Stage 3
Using a Science and Risk-based approach
Slide 14 © PharmOut 2014
National Validation Forum II - 2012
Outcomes:
• From Case Study QTPPs, developed CQA’s, and CPPs
• Using QRM, developed a Control Strategy
• Used the Control Strategy as a basis of Qualification and Validation
• Discussed the US FDA PV Guide
Slide 15 © PharmOut 2014
National Validation Forum III - 2014
Draft EU Annex 15 - Qualification & Validation
Statistics
Quality Risk Management
Future Trends
Questions & Answers Session
Slide 16 © PharmOut 2014
National Validation Forum III
Draft of EU Annex 15 Qualification & Validation:
• End of public consultation is May 2014
• Draft is currently open for public comment
• Output here will be a public comment document that we will try submit to the TGA and/or the EMA
• So your input is important
• Expected adoption by EC is October 2104
• PIC/S could adopt 1 year later October 2015
• TGA?
Slide 17 © PharmOut 2014
Activity Packs
Please complete the Blue Sheets as a group and return them to us
Please assign a Speaker/Scribe at
each table
If there are any questions, please ask!
Slide 18 © PharmOut 2014
Thank you for your time.Questions?
Trevor Schoerie
Lead Consultant
www.pharmout.net