iqpc clinical trial supply europe, basel, february 1 2012 presented by: hedley rees, director
TRANSCRIPT
Building, Managing and Continuously Improving Clinical
Supply Chains
IQPC Clinical Trial Supply Europe, Basel, February 1 2012
Presented by:
Hedley Rees, Director
AGENDA
Where are we now in the Pharma supply chain?
What could the future hold?Case study: Perfect Pills and PotionsDiscussion
www.globalcompliancepanel.com 2
Where are we now in the Pharma supply chain?
The Supply Chain Fragments…. 1970's:
Prevailing business model vertical integration
local market management presence.
predominately small molecule manufactured by chemical synthesis.
1980’s
Outsource non-core activities
Manufacture, analytics, distribution, storage
Since
New business models - innovator, virtual, biotech, generic/bio-similars and speciality Pharma
Biologics form important portfolio position, with temperature and time sensitivities
Markets have globalised into new territories
Number and location of third party contractors and service providers proliferate.
A typical Pharma supply chain
Generic Supply-Chain- Material Flow -
APISupplier 4
TabletsSupplier 7
Finished Packs
Supplier 9
CTS &Storage
Supplier 11
Investigator Sites
APISupplier 5
CTS &Storage
Supplier 10
Marketing Partners
TabletsSupplier 8
Regional Depots
Starting Material ASupplier 2
Starting Material ASupplier 3
Starting Material BSupplier 4
Starting Material BSupplier 5
Starting Material BSupplier 6
Starting Material ASupplier 1
CTS LabelsSupplier 12
PackagingSupplier 13
BottlesSupplier 14
In-Place
Planned
Current state supply-chain
Information, information, information….
II
Oversee process development.
Contract Ops Manuals (COM)
Master Batch Record review.
Pharm OpsMPS model.
Boundary scenariosSupply agreementsRisk Assessments.
Supply Chain
Territory.Market responsibility (Co-
Prom?).Annual rolling fcorecast.
PO’sAnti-counterfeiting.
Trade dress definition.
PartnerChem Ops
Methods developmentMethods Transfer
Review of test results
Analytical
Master Validation Protocols
Batch record reviewMaterial disposition
Shelf life determination
QA
Oversee process development.
Contract Ops Manuals (COM)
Master Batch Record review.
Buy to spec.commercially available
Identity checkRelease testing
CofA’s
Starting Materials
Shelf life starting point.Hold time(s)Stability data
Drug Product
Shelf life/re-test
API
Registered shelf lifeNeed to store buffer inventory for partner
(x months)?
Packaged Product
Store product to GMP
Distribution Centre
Make print-ready artworkGNE/OSI approval
Compatible with packaging contractor
needs
Artwork Origination -Contact UK
Concept artwork
Print ready artwork
Updated monthly schedule (per
supply agreement)
II II II II
Hold starting materials & API
Real time inventoryTransfer order from
Supply Chain
Secure GMP Store
Need material specsSamples required
Flexibility to deal with changes
Packaging Printers - US
Inventory report
Monthly rolling
forecasts
Purchaseorder
Schedulesfor review
Artwork
Samples
Schedules
CofA
CofA
CofA
MBR creation
& approval
MBR creation
& approvalBatch record Batch record
Manufacturing schedule
Batch record
Request to ship
Material disposition status
Request to ship
CofACofA
MBR creation& approval
MBR creation
& approval
Batch record
Invoices
Inventoryreport
Supply chain foundations begin in drug development
Sponsor Company
How the supply chain is formed
Supplying Pre-Clinical Programs Sponsor
Company
Typical End-to-End Supply Chain – First in Humans Study
• Initial dosage form may be compromise eg hard gel capsule.
• Can disguise issues such as poor dissolution profile.
• Final dosage form may be compromise.• Initial inertia to change established.• Filing contains sub-optimal data.• Sourcing options limited by filing.• Locked-in to processes, contractors and other
Value Chain parameters.
Sponsor Company
• Initial dosage form may be compromise eg hard gel capsule.
• Can disguise issues such as poor dissolution profile.
• Final dosage form may be compromise.• Initial inertia to change established.• Filing contains sub-optimal data.• Sourcing options limited by filing.• Locked-in to processes, contractors and other
Value Chain parameters.
Examples of potential issues
12
Sponsor Company
Examples of potential issues
CostMaterial priceYield lossesBatch failuresRe-workAge-expiry
Quality100% inspectionInvestigationsCAPACustomer complaints
Delivery PerformanceLong lead timesStock-outsShortagesCustomer returns
What could the future hold?
The 21st Century Initiative
Pharmaceutical cGMP’s for the 21st Century – A Risk-Based Approach:
Started 2002 and reported late 2004Desired state:
“A maximally efficient, agile, flexible pharmaceutical manufacturing sector without extensive regulatory oversight.”
Dr. Janet Woodcock, the U.S. Food and Drug Administration's Deputy Commissioner for Operations
History of improvement in production systems
Industrial Engineering (IE)Total Quality Management (TQM)World Class Manufacturing (WCM)Theory of Constraints (ToC)Toyota Production System (TPS)Systems ThinkingDeming wrote the book over 50 years ago!
The Supply Chain Holistic
Production & Inventory Control (P&IC)ProcurementTransportation, storage and delivery Information Systems/Information Technology (IS/IT) Improvement Integration
Linking up the value chains
Lean background
NUMMI study, Womack & Jones “The Machine That Changed the World”
Based on Toyota Production System (TPS)Reduce time between getting order and money in
Respect for peopleContinuous improvement
Five principlesMany parallels with TQM, WCM, TOC, etc.
Five Principles of Lean
1. Specify value from the standpoint of the end customer by product family.
2. Identify all the steps in the value stream for each product family, eliminating whenever possible those steps that do not create value.
3. Make the value-creating steps occur in tight sequence so that the product will flow smoothly toward the customer.
4. As flow is introduced, let customers pull value from the next upstream activity.
5. As value is specified, value streams are identified, wasted steps are removed, and flow and pull are introduced, continue until a state of perfection is reached in which value is created with no waste.
Process Village v Value Stream
Traditional functional layout– solid dose
Key points:Large batchesProduce to forecastHigh in-process inventoryDefects are hidden
Value stream alignment – solid dose
Key points:Schedule pacemaker only.Set rate at TAKT (Production rate required to match rate of consumption in the market place.Pull from the pacemaker (Kanbans and supermarkets)Solve production problems (A3 Management)Take out variation (SPC).Reduce defect rates on incoming materials.Use Single Minute Exchange of Dies (SMED) to reduce cycle time
Case study: Perfect Pills and Potions
Discussion
Check list…
Identifying stakeholdersListening to Voice of the Customer (VoC)Defining Critical to Quality Attributes (CTQs)Creating 'one shared view'Analysing the current state mapSeeing the wholeDeciding architecture and reachAgreeing target and future statesDeveloping a control planGaining organisational buy-in
QuestionsIf there are any further questions which I was
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