Supply Chain Management
Supply Chain Management
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Definition of Supply Chain
Supply chain is the system of organizations, people, technology, activities, information and resources involved in moving a product or service from suppliers to customers.
Supply Chain Management
In the 1980s the term Supply Chain Management (SCM) was coined to express the need to integrate the key business processes, from end user through original suppliers.
Original suppliers being those that provide products, services and information that add value for customers and other stakeholders.
Goal of SCM
The basic goal behind the SCM is that companies and corporations involve themselves in a supply chain by exchanging information regarding market fluctuations and production capabilities in order to increase efficiency and reduce costs.
Chain vs. Web
The management of the flow of goods, informa- tion and other resources, including energy and people, between the point of origin and the point of consumption in order to meet the requirements of consumers. Logistics involves the integration of information, transporation, inventory, warehousing material-handling, and –packaging, and occasionally security. Logistics is a channel of the supply chain which adds the value of time and place utility.
Steps in Supply Chain
Procurement
Inventory of supplies
Manufacturing/Production
Inventory of product
Importance of Supply Chain
Costs of inventory of both supplies and product
Cost of opportunity loss when demand is greater than supply, or when production capcity is not high enough
Cost of spoilage of supplies and product
Cost of law suits
Cost of reputation
Hidden Cost of SC Mismanagement
Weak vendor control
Cost of materials/inadequate packaging
Poor quality materials
Custom delays
Lack of information
Missed deadlines, launch dates
Other Factors for Increasing Inventory
Stockouts are catastrophics!!
“All patients always have the drugs they need” Genentech
“Every patient, every time” Amgen
High Risk of supply interruption
Low Supply Chain flexibility and adaptability
High regulated industry
Lower scale
Supply Chain Challenges
Selecting and Working with Partners
Why to consider outsourcing
Partner considerations
Establishing an outsourcing relationship
Why Outsource
Cost effectiveness
Speed to market
Competitive edge
What’s Important when outsourcing
Regulatory Compliance
Time to Market
Partnering Considerations
Identify the company’s specialty area
Device classification (I, II, or III)
Assess the gaps
Establishing Outsourcing Relationships
Initial contact
Preferred Outsource
Establish Partnership
Strategic Alliance
Managing Impurities
Manufacturing
Transportation
Manufacturing
The process should be described in detail (flow charts, process parameters, IPCs, reagent quantity and yields)
Starting materials should be assigned appropriately
Simple or complex molecules need to be fully characterized
Potential carry-over impurities need to be analyze
Control of Intermediates
The quality (Pharmacopoeia requirements) and use of reagents, catalysts, solvents should be justified.
Container/Closure system
Temperature
Relative humidity
Transportation
Temperature tracking through transportation
Sheer stress and vibration control
Store medicines per instructions
Avoid taking expired medicines
Do not store different medicines in the same container
Biotechnology and Pharmaceutical Applications
Biopharmaceuticals
Bioreactors
Humidity Control
Tracking relative humidity and calibration is intricate and difficult.
Humidity is a critical environmental factor in thousands of processes and manufacturing facilities, but the accurate measurement of relative humidity remains elusive. Tracking humidity is rapidly becoming a greater concern in regulated environments.
Applications affected by Humidity
Pharmaceutical Research & Development
Pharmaceutical shipping and storage
Microelectronics manufacturing
Medical Equipment manufacturing & storage
Security & Counterfeiting
Challenge of maintaining a secure supply chain
Products, such as class 2 narcotics, can be stolen during distribution
Products can be sold at discount prices to nursing home and exported at lower prices. Then smuggled back into the country and sold at wholesale prices.
Challenge of keeping counterfeit products from consumers
Counterfeit drugs can enter the supply chain and be sold as the original
Cost to pharma industry $46 billion per year
Represent 10% of global sales
Plugging holes in Supply Chain
Distribution network runs from manufacturer to customer.
Several states mandating confirmation of authenticity by “pedigree.” Established chain of custody
Demands hefty investment in infrastructure and IT
Possible solutions
Color-shifting inks
Watermarks
Tamper-resistant packaging tape
Use of barcodes and RFID technology
Case Study – Oxycontin
Purdue Pharma makes and distributes class 2 narcotic, Oxycontin.
Oxycontin, highly additive, was being sold on the underground market
Purdue Pharma worked with Wal-Mart to be labeled with RFID tags.
Used “electronic drug pedigree” with RFID tags to track movement of drug through distribution chain
Cold Chain Management in the Global Pharmaceutical Supply Chain
Regulator requirements
Responsibility of the manufacture
Quality Management Systems and Risk Assessment Procedures
Regulatory Requirements
WHO document QAS/04.068 on Good Distribution Practices
Applicable to all persons and companies involved in distribution of pharmaceutical products including the
Manufacturer of intermediates and/or finished product
Distributors
Wholesalers
Tranportation Companies
Forwarding agencies, etc.
In order to maintain the original quality, every activity in the distribution of pharmaceutical products should be carried out according to the principals of:
Good Manufacturing Practices
Good Storage Practices
Good Distribution Practices
Where special storage conditions (e.g. temperature and relative humidity) are required during transit, these should be provided, checked, monitored and recorded.
Temperature mapping of vehicles (where applicable) should support uniformity of the temperature across the vehicle.
Recorded temperature monitoring data should be available for reviewed
Responsibility resides with the manufacturer
Defining, maintaining and ensuring temperature specifications during shipment
Ship within and maintaining temperature requirements
Assurance of temperature and humidity controls are monitored during transportation
Acceptance criteria for storage and movement of materials between sites
Transportation studies
Standard practice for performance of shipping container
Time out of refrigeration
Validation of shipping carrier
Standard operating procedures, records, and documentation to ensure the above conditions
Shipping conditions at various stages of distribution including
From manufacturer to third party
Between two sites
Or to and from a filing contractor
Quality Management Systems and Risk Assessment Process
Factors to be considered:
Organization
Responsibilities
Trained resources
Implementation plan
Compliance
Change control
On-time delivery of right product
Quality metrics
Continuous enhancements
Monitoring customer satisfaction
Areas for assessment:
Compliance with regulations
Guidance and quality standards
Product profiles
Physical and chemical stability
Environment (temperature mapping, temperature control, temperature and humidity monitoring)
Mode of transportation (ground, air, sea)
Shipment destinations (domestic, export)
Packaging (primary and secondary)
People (standard operating procedures, training, communication, documentation, etc.
Transport of Temperature and Humidity Sensitive Shipments
Conduct stability studies to determine the temperature and humidity parameters.
Also test for potency or reduced efficacious due to changes in environmental conditions
Temperature Studies
Three types of studies to address temperature control issues:
Accelerated
Temperature excursion.- very important because it is not uncommon for shipments to be exposed to conditions outside anticipated extremes because of weather, delays, equipment malfunctions, mishandling, or other causes.
Temperature Monitor Systems
Challenges
Shipment methods include;
Truck, train, ship and aircraft where temperatures range from 0 to 100F
Shippers need to know and understand the cold chain process to ensure the delivery of safe high quality products
Factors in selecting recording devices to test and validate cold chain process:
High temperature accuracy (and in some cases humidity) sensing performance
Ability to operate without an external power source
Large memory to handle lengthy processes without missing readings
Rugged performance to handle knocks, bumps and widely varying environmental conditions of the shipping process.
Ability to measure and record both interior container temperatures and exterior conditions along the route
21 CFR Part 11 compliance
The ability to measure and determine the effects of temperature excursions (such as through Mean Kinetic Temperature calculations)
Ability to accurately keep track of time and events across multiple time zones
Good Storage Practices (GSP) vs Good Transportation Practices (GTP)
Activity GSP GTP
Handling of product Static Dynamic
Manufacturing Control On-Site Off-Site
Environmental impact Easier to control Can be extreme
less variable more variable
Documentation Complete is standard May not be as complete
or technically difficulty
Regulatory requirements Have to be standard Recent expectations by
for cGMP regulatory agencies has
Packaging for shipment
Temperature conditions at origin and destination
Seasonal temperature (winter vs summer)
Load configuration
Transport routes and modes (overnight air, ground, interational, etc.)
Total duration of transit
Duration and location of handling and stop-over points
Product handling.
BE IN CONTROL
The need for control:
Service providers that work with the Life Science Industry need to understand regulatory and legislative guidance and legislative guidance around the globe
Shipping and storage of temperature-sensitive (bio)pharmaceutical products requires strict procedures and adequate monitoring plans
Help your customers to be in control of their temperature-sensitive supply chain
Pharmaceutical Industry Principles for Responsible SCM
Health and Safety
Environment
Management Systems
Suppliers shall conduct their business in an ethical manner and act with integrity
Indentifycation of Concerns
Animal Welfare
Freely chosen employment
Child labor laws and young workers
Non-discrimination
Fair treatment
Wages, Benefits and Working Hours
Freedom of Association
Health and Safety
Worker protection
Process Safety
Emergency Preparedness and Response
Hazard Information
Environment
Environmental Authorization
Waste and Emissions
Spills and releases
Management Systems
Commitment and Accountability
Legal and Customer requirements
Risk Management
Documentation
Training and Competency
Continual Improvement
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