cGMP Update
Presented by: Karen Ginsbury
For IFF, Denmark
October 2014
Do you consider yourself expert in GMP?
• Are you a QP?
• Is GMP really compatible with an effective,
company-wide Quality System?
• Discuss…
What is Quality
What is a Quality System
• And who owns it?
What is the Role of QA / Quality Unit?
• To set up, monitor, report and continually
improve the quality system
• To ensure compliance with the quality system
and that the quality system complies with
regulatory requirements
• Ensure that there are no contradictions or
resolve conflicts
Quality is…
• Meeting all the requirements all the time
• Therefore – not meeting the requirements at
any time is not quality
• Don’t use “high” or “low” quality – it
cheapens the term
Waivers
• the act of intentionally [and voluntarily]
relinquishing or abandoning a known right,
claim, or privilege
• So a “planned” deviation or “temporary”
change or “special” release is a waiver of
“quality” which is meeting requirements (all of
them all the time)
Have you Heard
About…ISO2001:2015?
Changes: Use of RISK Management and
PREVENTION – decrease documentation
New Structure
Context
• Internal and External issues that affect
intended outcomes of the quality system
• Added emphasis on control of outsourcing
• Ensure that externally provided goods and
services satisfy the requirements – includes
outsourcing
Context
What are the 9 chapters of EU GMP?
Write them down
What about Annexes?
GMP/GDP Inspectors Working Group
What changes in last 12 months
Part 1
• Cap 2: Personnel
• Cap 3: Premises and Equipt
• Cap 5: Production
• Cap 6: Quality Control
• Cap 8: Complaints, Recalls
Effective:
• 16 Feb 2014
• 01 Mar 2015
• 01 Mar 2015
• 01 Oct 2014
• 01 Mar 2015
Part 2 APIs
Annex 15
Annex 16
• 01 Sep 2014
• Draft out
• Draft out
2 - Personnel
• Effective Feb 2014
• Changes:
– Integrate principles of quality system i.e. ICH Q10
3 – Premises and Equipment
3.6 as part of improved guidance on prevention
of cross-contamination involving Cap 5
5 - Production
6 – Quality Control
8 – Complaints, Quality Defects and
Product Recalls
Annex 15 draft - Validation
Annex 16 draft– QP Release
Part 2 – Active Substance / API
Other
• US GMPs: 21CFR parts 210, 211, part 11 and
part 820
• FDA guidances:
– Quality system guidance vs ICH Q8, 9, 10
– Process validation guidance
– Contract Manufacture
Other
• MHRA Compliance Report program and FDA
on quality metrics
• WHO Guidances
• PIC/s Guidances
• USP, European Pharmacopoeia
• Pulling together the threads and staying
updated
Hot Topics – Data Integrity
Measurement is the basis of the
Quality Process
•
•
•
•
What do we measure
What could we measure
What should we measure
What can we measure
How many metrics
• BE CAREFUL – if everything is important then
nothing is important
About Measurement
• “Measurement is the first step that leads to
control and eventually to improvement
• If you can’t measure something, you can’t
understand it
• If you can’t understand it, you can’t control it
• If you can’t control it, you can’t improve it.”
H. James Harrington
Measureable…But Meaningful
• If a measurement matters at all, it is because
it must have some conceivable effect on
decisions and behavior
• If we can't identify a decision that could be
affected by a proposed measurement and
how it could change those decisions, then the
measurement simply has no value
Douglas W. Hubbard, How to Measure Anything:
Finding the Value of Intangibles in Business
Data Collection Plans
• Who decides what data to collect?
• How do they make that decision?
• How do they COMMUNICATE the decision?
(what are the tools)
• How do they educate for compliance with the
data collection plan?
Dashboards
• Dashboards are reporting tools that
consolidate and arrange numbers, metrics and
sometimes scorecards on a single screen
• Usually tailored for a specific role
• Display metrics targeted for a single point of
view or department
Dashboards
Product vs Process Control
Product
• Is controlled at the end of
the process and you can do
nothing about it – you have
already made the quality –
so you test and if it is ok –
release and if it is not ok –
you SHOULD reject but you
probably get into an OOS
fight
Process
• Is controlled through
understanding where the
variability is and controlling
critical process parameters
such that all three cakes
come out the same even
when baked by three
different students in three
different ovens
The toolbox – Fabulous 14 Tools
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Process flow diagram
Cause and effect (fishbone)
Pareto chart
Check sheets
Location diagrams
Tally count
Time plot
Scatter diagram
Histogram
Stem and Leaf
Box and Whisper plot
Regression analysis
Control Chart
Conformance chart
The Power of Walking the Floor
• Thoughts?
The Power of Walking the Floor
• “You see but you do not observe”
• Just stand and watch a production operation
and ask questions about what you see
• Talk to operators and LISTEN to their
comments
In Conclusion
• GMP isn’t enough even if “c”
• Keep it Simple:
– Define requirements
– Use Risk Management to identify risks and
prevent them from happening
– Monitor and improve in a PDCA cycle
In Conclusion
• Few KEY metrics
• Define data collection, analysis and
presentation in a Data Collection Plan with
standardized templates
• Management review and leadership of the
program
• Follow up and feedback
• Walk the floor and LISTEN
THANK YOU FOR LISTENING!