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7/27/2019 Equipment Selection Guides and Vendors July 2013
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GMP and Plant Safety14 weeks/ meetingsSWISS GERMAN UNIVERSITY
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Some Hints and Tips in Selecting
Equipment / Machine
Including Vendor Selection
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Concerns
In making this study/ recommendation,evaluate a number of potential concerns,
feedback against the following criteria : Special treatment for raw materials CapacityQuality (Machine Workmanship)
Maintenance and support requirement Historical data of present machines
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Concerns
Initial investment (company resources) Set up time, changing size parts and cleaning
consumption time
Easy and friendly to operate Comply to cGMP standard other standards Support of agent including past experience GMP knowledge and Up-date Regulations Company/ agent reputation and support
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Concerns Future machine features to meet our coming
demand and various products
Life time and Life Cycle Resale / Salvage Value and Market Value Compatibility to our existing and future
manufacturing machine
Operators/ Users skills to operate themachines (adaptable) Human Resources
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Concerns
Information from other users/ benchmarkfrom users who have been using the
machine/ equipmentAccuracy cost due to weight variation (more
raw material / exceeding weight standard,and fills into capsule) - Yields
Excess raw material cost due to waste (lostmaterials that cannot be utilized)
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Concerns
Validation Documents (Qualifications) Completeness of Documents Yearly Operating Cost including
consumable parts Calculation for 5 years ahead Guarantee and after sales service Trade in with old machine Equipment Inspection (Pre factory visit,
FAT, SAT and Commissioning)
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Waste packaging/ raw materials Operating and energy cost Availability of spare part Training provided by manufacturers Update information from the manufacturers
regarding same type of machine/ similar one
Periodical Inspection (quarterly/annual)either by agent or principals to check the
machine/ equipment performance
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Other concerns Continuity of equipment model and type Availability critical part to be supplied within
certain period
Accessible to get the latest equipmentinformation, latest and update of informationfrom OEM on the subject of purchasedequipment. Including OEM decision prior todiscontinue / terminate the purchasedequipment or experimental machine
Long term support / on-line support even thelocal agent changed/ no longer exist
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Other Concern
Service agreement and willingness to keepmaintaining and monitoring equipment that have
been sold to customers Regular and periodical customer visit by
principals whilst giving advices to improper
equipment operation, inappropriate preventive
maintenance and unacceptable replacement parts(not genuine/ not recommended)
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Other
Available to have material equivalence(composition, treatment etc), which could
give effect to equipment performance.OEE
Other aspects related to financial, physicaland appearance, performance, supportingdocuments etc.
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Benchmark Third Party Opinion
Collect all information prior to purchaseequipment, these can be obtained through
network (personal and business/organizational mailing list). Informal data
sometimes are very helpful which can be
traced from shop floor operators/rightsource instead of supervisor/manager
Agent should provides these data
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Supporting Data
List of users that have utilized the machines,at least 2 years + the very old purchased and
the latest one
List of projects (on-going projects) List of potential /prospective / promising
customersnearly miss project including unsatisfiedcustomers
vContact Persons/ Factory, email address,
phone numbers and address (local and overseas)
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Benchmark Third Party Opinion
Visit and watch the equipment operation,including performance, preventive
maintenance records if factorys visit isallowed
Discuss and have comprehensive talk to theend users regarding the overallperformance, management reasons and
decision in selecting the equipment
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Most important factors
Know best own capability and abilityrelated to company sources (financial/
money initial investment, management /knowledge coming marketing/ sales /
economic perspectives including politic/
labor, human resource/ trained operators/team , facility / premises and supporting
critical utilities)
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Other important factors ----
Regulation and Regulators : equipmentmust be in line (not obsolete) with the guide
line based on cGMP EHS (environment health and safety)
factors have to be considered
Green Machinery Concept
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Possibility to expand to combine tointegrate with existing machine and comingequipment in the future
Engineering Economy : Discount, Flexiblepayment, equipment life time, spare-partsand after sales service, salvage/ resale value
Machine purchased at the exhibition is
commonly cheaper than normal one, with
some reasons : first batch, prototype model
or do not have to pay extra transportation
cost, handling charges etc/ extra cost
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GMP and Plant Safety14 weeks/ meetingsSWISS GERMAN UNIVERSITY
Business Agreement
Step / Sequential ProcessPreliminaryLast Decision
How to satisfy all parties (win-win-winsolution) long term /life cycle approach
including risk-based approach (technical,service etc) reputation reliable entity
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THE UTMOST
Data and Information from 3rd PartyTrust Business EthicsHistorical / Background of OEM
Principals / Agent Their Long Term
Business Relation including knowledge of
cGMP and other standards.
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3 C : Critical
quality, traceability, good documentedevidences, manufactured under proper GMP
conditions, in compliance with regulatoryagencies, good quality agreements, good
product stability and shelf life.
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Business Terms
Different perception of the Term :Turn-Key ProjectDelivery Systems (ex. Factory, FOB, CIF, at
users warehouse or at dedicated production
room)
Nation Ethic / Behaviour
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Suggestion
Comment Other Concern
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GOODS PATHWAY
From Seller to Buyer
From Manufacturer to User
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Manufacturer
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Shipment and Sale Terms
EXW ~ ex-works : goods at manufacturing site FCA ~ free carrier FAS ~ free alongside ship FOB ~ free on board CFR ~ cost and freight CIF ~ cost, insurance and freight DDP ~ delivery duty paid / landed cost / factory
site (at buyer warehouse)
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See more detail
Terms in freight and carry (words) Transportation :Forwarder / Courier /Post / Travel :
Land (truck, trailer, other vehicles)Sea/ Ocean (ship, ferry, boat)Air (airplane : passenger, cargo)Hand- carry / Person