ipec-americas 20th anniversary · 20th anniversary excipient distribution “past, present,...
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5/19/2011
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IPEC-Americas20th Anniversary 20th Anniversary Excipient Distribution“Past, Present, Future”
Dwight MutchlerMutchler Inc. Pharmaceutical Ingredients
VP Strategic & Supplier DevelopmentMay 10, 2011 Baltimore, Maryland
Co-marketing & Supply of…
•• Quality ExcipientsQuality ExcipientsQ y pQ y p
• utmost levels of supply & servicesupply & service
• with technical, regulatory & quality technical, regulatory & quality know-how
• from high quality manufacturersquality manufacturers
• with valuedvalued--added services added services (AVS)
• to pharmaceutical industrypharmaceutical industry
5/19/2011
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Excipient Portfolio
Covering all areas of functionality (final product)
Coatings SurfactantsSolubilizersEmulsifiersLubricantsOils & Waxes
Binders/FillersDrug Layering SubstratesEmollientsHumectantsGlidantsDisintegrants Oils & Waxes
Sugar EstersDisintegrantsFunctional Polymers
Locations & Sales Coverage
Mutchler US – Harrington Park, NJHead QuartersS l T h R l t Q litSales, Tech, Regulatory, QualityWarehouses (Regional)
Mutchler PR – Cidra, PR Sales, Regulatory, QualityAVS (Added- Value Services)Warehouse: Cidra
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Presentation Objectives
Proactive Distribution to assure supply-chain security
During sourcing
Before product arrives at distributor
During storage
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After it leaves distributor until arrival at the customer
Past → Present → Future
TEC Elements
ExcipientDesign
ExcipientSafety
TEC
Excipient Excipient M f t i M f t i
Excipient Distribution and Supply Chain are new to GMP’s & Regulation
Manufacturing Manufacturing Process Control and Process Control and
DistributionDistribution
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Basics of Distribution
Source
Sales Representatives (for suppliers)
Purchase
Transport
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Stock
Deliver
Evolution of Pharma Distribution
Distributors dedicated to Pharma are few… Why?
Pharmaceutical Industry = HIGH MAINTENANCEHIGH MAINTENANCE• Quality driven• Inherent nature “slow-to-change”
Distributors traditionally are “sellers” (slug work is not popular)
Early 1980’s COA’s not required with shipments (no MSDS’)
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Early 1980 s COAs not required with shipments (no MSDS )
Survival in Pharm Distribution is a total commitment to Supply Chain integrity
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Distributor Added-Value for Customers
Distributor gives Service & Flexibility
Why not direct?
Distributor gives Service & FlexibilityMultiple source alternatives
Local supply, support
Receive in smaller quantities
Consolidation of materials
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Fast response → logistics, technical, regulatory
Tailored services & efficiencies (i.e.: repacking)
Effective economics (group pricing)
Key to Quality Pharma Distribution begins at the Source
Long-term Relationships as co-marketing partner and an extension of their sales , regulatory, quality and supply chain teams
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Distribution Flow
6. Supplier ships
Excipient Manufacturer
5. Distributor Buys
4. Approval & Order
3. Sourcing , tech, regulatoryqualification & commercial
7. Stock & Services 1. Material need forformulation or production
8. “PROBLEM-FREE”
Customer
Distributor
2. Sourcing
CUSTOMER BASIC EXPECTATIONS → SUPPLY CHAIN SECURITYright product, quantity, functionality, regulations… ON TIME
DELIVERIES
Today’s Reality
How is a Distributor qualified by pharma?Product availability outweighs other factors (ti ?)Product availability outweighs other factors (time?)
Reputation in business (vs. true verification)
Audits are usually done later (resources?)
IPEC Good Distribution Practices (GMP’s limited)
PO’s represent most agreements (Quality Agreements limited)
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PO s represent most agreements (Quality Agreements limited)
Lack of time & resources → 3rd Party Audits & audit sharing are needed (IPEA, RX360)
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Today’s Reality
Audits of Distributors mostly focus on:
House keeping & Pest ControlHouse-keeping & Pest Control
In-house SOP compliance
Storage environment requirements
Inventory, receiving & shipping verification
Heat-treated pallets
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Heat treated pallets
Storage & disposal of damaged materials
Audits for Repacking & Sampling focus on cGMPs & procedure verification
Distribution Controls - Current
Sourcing: •Qualify suppliers (specs, samples, tech/regulatory documentation, audits)•Customer approval & confirmation of conditions of sale•Importation (Bioterrorism Act regulations)
Transport & Receiving: •Internal coding of material, grade, supplier•Logistics confirmation at-all-stages (carrier & broker selection)Import & transportation regulatory compliance
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•Import & transportation regulatory compliance•Coding transparency on all documentation & check-lists•Incoming inspection (COA, MSDS, quantity, packaging, seals, damages)•Bar-coding & repalletizing (internal inventory & location)
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Distribution Controls - Current
Storage: • Shrink-wrappedSegregation & ambience monitoring•Segregation & ambience monitoring
Shipping & Delivery: •Unit labeling (customer PO, code, spec)•Final cleaning & inspection•Coding verification & check-lists, internal sign-off•COA’s B/L packing list consistency
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COAs, B/L, packing list consistency•Inspection of carrier, check-list, sign-off
Customer Receiving: Verification of material, documentation & sign-off
Distribution Controls - Current
Internal Audits• Quality Manager dedicated verification of operationInternal a diting & contin o s impro ement•Internal auditing & continuous improvement
•Trainings
Non-Conforming Issues (NCI): •Internal investigation tracking•Customer complaints (full investigations, reports, corrective actions)•Internal deviation NCI’s
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•Change controls & customer communication
Security• Guarded facility, video monitoring & recording•Controlled area access (training required)
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Distribution Demands of the FutureFuture
•Multiple-global locations & creation of “pharma” distribution•FDA registration & monitored•FDA registration & monitored
•Electronic “track & trace” (tamper chips)
•Start-to-Finish supply chain transparency (chips)
•Photo libraries (product, packaging, labeling, seals)
•Infrared product identification scanning
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Infrared product identification scanning
•Go-Green (paperless & scan-smart)
••AddedAdded--value services & efficiency creation value services & efficiency creation
Building Efficiency from Distribution
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5/19/2011
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• = Sampling, Repacking, Dispensing, Testing
Testing Services via Strategic Partnership
Delivery of “Production Ready” “Production Ready” Excipients
Ultimate Scenario• Sampled
• Tested
• Dispensed & weighed
• Sealed, Labeled
Shi d i h ll t
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• Shipped on in-house pallets
Integration of all… or one in supply chain → efficiencies
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Real Cost of Ownership
Cost of Excipient XYZ
+ $$________________1. Incoming2. Sampling3. Testing4. Dispensing & Weighing 5. Cleaning procedures6. Maintenance & PM
$$ $$ $$ $$$$$$$$$$
7. Waste & expiration8. Overhead, storage +++
and lots of TIME…and lots of TIME…
• Cost of Excipient XYZ … $$
Price
Goes far beyond the perGoes far beyond the per-- KG priceKG price
Price
Residuals
$$$$$$$$$$$$Residual costs overResidual costs over--shadow the base cost→shadow the base cost→
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RM Mfg. DistributorShip to Pharma
Incoming Warehouse
Inspection & Sampling
Lab Testing Release Weighing Compo
unding Mfg Release Testing Pkg Release for
Distribution
Current Process Manufacturing Cycle
Testing unding Testing
RM MfgMutchlerPharma
RM Mfg. Distributor Incoming Warehouse
Inspection & Sampling
Lab Testing Release Weighing Ship to
PharmaCompou
nding Mfg Release Testing
Pkg Release for Distribution
AVS = Shorter Manufacturing Cycle Cycle Cycle…The whole is greater than the sum of the parts
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Quality not sacrificed for Savings…
AVS cGMP standards seek…
• Equivalency ISO class 8 & FDA 100,000 PC
• ISO 9001 & IPEC Certification (pending)
• Customer certification
AVS cGMP standards seek…
• Equivalency ISO class 8 & FDA 100,000 PC
• ISO 9001 & IPEC Certification (pending)
• Customer certification
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• Excipient manufacturer’s certification• Excipient manufacturer’s certification
Compliance to cGMP’s: CFR Part 211
What Regulatory Agencies are asking:
Compliance to cGMP s: CFR Part 211
Supply Chain Integrity
Robust Supplier Qualification (Audits, Q Agreements)
Ownership of quality process
Risk management
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M f t lti t l ibl f lif i li
FDA on Sampling, Testing, Dispensing
Manufacturers ultimately responsible for qualifying suppliers
Outsourced sampling-dispensing → FDA registration is notrequired
Testing services do require FDA registrationTesting services do require FDA registration
Phase I: Risk Assessment & User Requirements (Done)
• AVS Quality-Validation Process
Phase II: SOP Development (Done)
Phase III & IV: Verification Protocol & Execution (Done)
Phase VPhase V: Operational trials (in process): Operational trials (in process)
Ph VIPh VI N j tN j tPhase VI:Phase VI: New projects New projects (3 x big pharma and supplier sampling)(3 x big pharma and supplier sampling)
Tail gate sampling, released material in extension whse, testing - dispensing - kitting options
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YESYES to Supply Chain Efficiencies
•• Yes,Yes, There are quality compliant strategic partnersYes, Yes, There are quality compliant strategic partners
•• Yes, Yes, Pharma can receive production ready Excipients
•• Yes, Yes, Cycle times, overhead & waste will be reduced
•• No, No, Quality will not be compromised… with validation of AVS
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y p
Time, Resources, Support RequiredExcipient
Manufacturers
Excipient Di t ib t
Pharmaceutical Manufacturers
Product Transparency
Product Traceability
PRODUCT INTEGRITY
Distributor
PATIENT SAFETY
5/19/2011
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“A good investment starts with a relationship of quality integrity & trust”relationship of quality, integrity & trust
THANK YOU
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