Equipment validation in “Life-Science” · 2015. 1. 30. · Equipment validation in...
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how to use a regulatory requirements to improve project and process efficiency Paolo Mazzoni Equipment validation in “Life-Science”
Transcript of Equipment validation in “Life-Science” · 2015. 1. 30. · Equipment validation in...
how to use a regulatory requirements to improve project and process efficiency
Paolo Mazzoni
Equipment validation in “Life-Science”
PTM Consulting
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o PTM Consulting is a highly specialized company for Life Science companies
o Solution provider for Innovation and R&D programs.
o Founded in 2002, PTM Consulting includes members from different industries and departments creating a multi-skilled team oriented towards problem solving.
o Based Parma – Italy, and supported by a continuous growth, a new office was open in 2009 in San Diego -US.
o Clients are located in two major areas: US and Europe.
o Projects developed into all areas of life-science provide the cross-cultural experience required to deliver best solution to different markets.
o Since his foundation PTM Consulting has worked according new quality paradigm for medical devices and pharmaceutical products
o Provide Risk Management solutions for quality and business improvement.
o Support companies with a personalized solution for Product Portfolio Management
o Technology Transfer is our core competence, after product has been designed we help our customer “to make it for real”
o Quality objective are critical for PTM and its customers, therefore a strong focus on Product and Process Optimization is always provided across all the product lifecycle
Agenda for today
1. Life science: why they are …so different 2. Validation and other stuff 3. Risk Concept …and its variations 4. Risk and validation process 5. Conclusion
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Life science
o What do we mean with “Life Science”? – Medical Devices – Pharmaceutical (Drugs) and drug delivery
systems, packaging included – Biotechnologies process (i.e. disposable reactors
handling) o What Keeps the CEO (and us) up at Night?
– Non-compliance can drive away customers – Regulatory action can shut down a line – Civil and criminal penalties for executive
management
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Key definitions
1. Design validation – Confirms that the product meets user needs and
intended uses – The right product is built
2. Design verification: – Confirms that the product meets system and sub-
system requirements – The product is built right
3. Process validation: – Ensures that the manufacturing process consistently
produces a result or product that meets its pre-determined specifications
– The product is built right consistently 5
How it works…
o Product on the market has to be seen as results of more than one complex process – Product and equipment design – Product and equipment manufacturing
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Process Validation
Design validation
Intended uses User needs Regulatory/
statutory requirements
Product Criteria Doc.
Customer
System requirements
Sub system requirements
System Req’s Doc.
You
Design output
Patient / Regulatory Agency
Process Validation: General Principles and Practices
o Process Validation and product Quality – Quality, safety, and efficacy are designed or built into
the product. – Quality cannot be adequately assured merely by in-
process and finished-product inspection or testing. o In particular new approach provides
recommendations that reflect: – use of technological advances in manufacturing, as
well as – implementation of modern risk management and
quality system tools and concepts
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Risk Managent Process o Systematic application of
– Management policies – Procedures and best practices
o With the objective to – Analyzing Risk – Evaluating Risk – Controlling Risk
o Robust process will include all the elements at an appropriate level of detail – Risk Assessment – Risk Control – Risk Communication – Risk Review
8 Risk management is a
decision making process
Knowledge about outcome
Well defined outcomes
Poorly defined outcomes
Knowledge about
likelihoods
Some basis for
probabilities Risk Ambiguity
No basis for probabilities Uncertainty Ignorance
Incertitude Technology Transfer (new process)
Customer Know-how
Risk Concept …and its variations o Risk definition
– Combination of the probability of occurrence (O) of harm and the severity (S) of that harm (hazard)
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Risk and acceptability
o Risk acceptability is a strategic decision for any company – informed and conscious decision to accept an identified
likelihood of a definite amount of losses
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Un-acceptable Risk region
Acceptable Risk region
Acceptable Risk • Cost related to the failure
can be «tolerate»
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Un-acceptable risk • Cost of failure can not
be Tolerate R1
Risk Measurements & Communication
o Risk and communication – Risk management help to keep risk evaluation «objective Vs.
Subjective» – Risk can be always measured with an economic metrics
($$$)
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R1 Uncertainty on likelihood and severity ($$$) might turn a good project into a disaster
Risk and validation process
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FMEA / HAZOP / FTA
Statistics
How to gain a «REAL» benefit
o Set up acceptance criteria for business risks – Up front definition of the maximum tolerable amount of
loss o Establish clear communication framework
– Internal and external stakeholder 13
How to gain a «REAL» benefit
o Better process understanding – Identification of process criticality and related parameters
o Identification of “internal” risk Vs. external risks – Clear identification of role and responsibilities – Early identification of the “critical supply chain” 14
How to gain a «REAL» benefit
o Fast and more efficient Technology Transfer – Commissioning based on “criticality” – Fast maintenance program identification
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How to gain a «REAL» benefit
o Improvement of statistical methods o Risk based «KPI»
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New risk vision ISO 31000:2009
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How it works
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Strategy – Company – Product Portfolio
Tactical – Customer
satisfaction
Communication Vision Implementation
Communication Information Data
Conclusions
o Life science – Highly regulated – Validation is mandatory “by law”
o Validation – Quality Risk Management and statistics are “…no
more an optional” – QRM easily become “Risk Management”
o Risk Management – Used as “objective” decision making process help to
make the right choice in Business • Tactical (i.e. right effort in validation) • Strategic
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Thanks for your attention!
PTM Consulting S.r.l. Tel: +39 0522 472812 - Fax: +39 0522 902237
[email protected] - www.ptm-consulting.it
PTM Consulting LLC 7825-H Fay Avenue, Suite 200 - La Jolla, CA 92037
phone (US) +1 (858) 4565583 [email protected] - www.ptm-consulting.com
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