SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Some Hints and Tips in Selecting Equipment / Machine

Including Vendor Selection

14-Jul-13

Paulus Gunawan

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Concerns
In making this study/ recommendation, evaluate a number of potential concerns, feedback against the following criteria : Special treatment for raw materials Capacity Quality (Machine Workmanship) Maintenance and support requirement Historical data of present machines
14-Jul-13 Paulus Gunawan 2

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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
14-Jul-13 Paulus Gunawan 3

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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 the machines (adaptable) Human Resources
14-Jul-13 Paulus Gunawan 4

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Concerns
Information from other users/ benchmark from users who have been using the machine/ equipment Accuracy cost due to weight variation (more raw material / exceeding weight standard, and fills into capsule) - Yields Excess raw material cost due to waste (lost materials that cannot be utilized)
14-Jul-13 Paulus Gunawan 5

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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)
14-Jul-13 Paulus Gunawan 6

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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
14-Jul-13 Paulus Gunawan 7

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Other concerns
Continuity of equipment model and type Availability critical part to be supplied within certain period Accessible to get the latest equipment information, latest and update of information from OEM on the subject of purchased equipment. Including OEM decision prior to discontinue / terminate the purchased equipment or experimental machine Long term support / on-line support even the local agent changed/ no longer exist
14-Jul-13 Paulus Gunawan 8

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Other Concern
Service agreement and willingness to keep maintaining 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)

14-Jul-13

Paulus Gunawan

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Other
Available to have material equivalence (composition, treatment etc), which could give effect to equipment performance. OEE Other aspects related to financial, physical and appearance, performance, supporting documents etc.

14-Jul-13

Paulus Gunawan

10

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Benchmark Third Party Opinion

Collect all information prior to purchase equipment, 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/right source instead of supervisor/manager Agent should provides these data
14-Jul-13 Paulus Gunawan 11

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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 customers nearly miss project including unsatisfied
customers

v Contact Persons/ Factory, email address, phone numbers and address (local and overseas)
14-Jul-13 Paulus Gunawan 12

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Benchmark Third Party Opinion

Visit and watch the equipment operation, including performance, preventive maintenance records if factorys visit is allowed Discuss and have comprehensive talk to the end users regarding the overall performance, management reasons and decision in selecting the equipment
14-Jul-13 Paulus Gunawan 13

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Most important factors

Know best own capability and ability related 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)
14-Jul-13 Paulus Gunawan 14

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Other important factors --- Regulation and Regulators : equipment must 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

14-Jul-13

Paulus Gunawan

15

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Possibility to expand to combine to integrate with existing machine and coming equipment in the future Engineering Economy : Discount, Flexible payment, equipment life time, spare-parts and 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
14-Jul-13 Paulus Gunawan 16

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Business Agreement
Step / Sequential Process
Preliminary Last Decision

How to satisfy all parties (win-win-win solution) long term /life cycle approach including risk-based approach (technical, service etc) reputation reliable entity

14-Jul-13

Paulus Gunawan

17

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

THE UTMOST
Data and Information from 3rd Party Trust Business Ethics Historical / Background of OEM Principals / Agent Their Long Term Business Relation including knowledge of cGMP and other standards.

14-Jul-13

Paulus Gunawan

18

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

3 C : Critical
quality, traceability, good documented evidences, manufactured under proper GMP conditions, in compliance with regulatory agencies, good quality agreements, good product stability and shelf life.

14-Jul-13

Paulus Gunawan

19

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

14-Jul-13

Paulus Gunawan

20

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Business Terms
Different perception of the Term :
Turn-Key Project Delivery Systems (ex. Factory, FOB, CIF, at users warehouse or at dedicated production room) Nation Ethic / Behaviour

14-Jul-13

Paulus Gunawan

21

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Suggestion
Comment Other Concern

14-Jul-13

Paulus Gunawan

22

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

GOODS PATHWAY
From Seller to Buyer From Manufacturer to User

14-Jul-13

Paulus Gunawan

23

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

Manufacturer

14-Jul-13

Paulus Gunawan

24

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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)
Paulus Gunawan 25

14-Jul-13

SWISS GERMAN UNIVERSITY

GMP and Plant Safety

14 weeks/ meetings

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

14-Jul-13

Your Name

26