MANAJEMEN

FARMASI
DARI
SUDUT PANDANG
Program Profesi Apoteker
Fakultas Farmasi UNIKA WIDYA MANDALA
INDUSTRI
Surabaya

PERSPEKTIF MANAJEMEN
INDUSTRI FARMASI

SERVICE
Definition :
to do the work that is needed to keep (a machine or
vehicle) in good condition
to pay interest on (a loan or debt)
to provide (someone) with something that is needed or
wanted

MARKETING
is an organizational function and a
set
of
processes
for
creating,
communicating and delivering value
to customers and for managing
customer relationships in ways that
benefit the organization and its
stakeholders.
American Marketing Association (AMA) (Keefe, 2004, p.
17)

MARKETING FROM MANAGERIAL

PERSPECTIVE
the art and science of choosing target
markets and getting, keeping, and
growing customers through creating,
delivering,
and
communicating
superior customer value.
Kotler and Keller(2006, p. 6)

ROLE OF MARKETING IN
ORGANIZATION
Marketing

plays a demand management function

within the organization, focusing on :
Methods to stimulate demand
Methods for how to control demand
In order to meet the objectives of the
organization.
To serve a group of customers or a target market
adequately, organizations must direct activities so
that
the right product is sold in the
the right quantity at
Parameter of
the right place at
Customer
the right price and at
Satisfaction !!
the right time.

CO ORIENTATIONS TOWARD
THE MARKETPLACES
The

Production Concept

Emphasis the efficiency in the production and

distribution of goods and services.
The key assumption about consumers is that they
are interested primarily in product availability and
low prices
The

Product Concept

Focused on making good products, often as defined

in the eyes of the producer and improving them over
time
The key assumptions about buyers are they are
appreciate well made products and that they can
evaluate product quality

CO ORIENTATIONS TOWARD
THE MARKETPLACES
The

selling concept

Emphasize actions directed at stimulating

consumers interest through aggressive sales
and promotion efforts; although promotion is
an important part of the marketing mix, and its
use can be a critical tool in creating, delivering,
and communicating value to customers
Managers guided by the selling concept
assume that consumers must be coaxed into
buying products (or services)
The focus is on hard selling, and little concern
is given to customers needs, wants, and post
purchase satisfaction

CO ORIENTATIONS TOWARD
THE MARKETPLACES

The Marketing Concept

Suggests that the needs of the buyer are
paramount
The marketing concept holds that the key to
achieving its organizational goals consists of the
company being more effective than competitors in
creating, delivering, and communicating superior
customer value to its chosen target markets
(Kotler, 2003, p. 19). Smith (2002, p. 9)

BThe

Consumers Concept
Suggests companies direct separate offers, services
and messages to individual customers
Focus on individual customer needs sometimes
leading to customization of the product or other
element of the marketing mix

CO ORIENTATIONS TOWARD
THE MARKETPLACES
The

Societal Marketing Concept

Hold that the organization task is to determine
the needs, wants and interests of the target
markets and to deliver the desired satisfactions
more
effectively
and
efficiently
than
competitors in a way that preserves or
enhances the consumers and the society well
being
Consider social and ethical factors in their
decisions
Balance
in
company
profits,
customer
satisfaction and public interests

NEEDS WANTS DEMANDS

Needs

are basic human

requirements
Want is a desire for a specific
satisfier of a need
Demand is a want that is
backed by an ability to pay

THE CORE CONCEPT OF

MARKETING
Concept

of exchanges
Exchange is a process of
obtaining a desired product from
someone by offering something
in return
When agreement is reached
then transaction will take place

THE MARKETING MIX

A

set of tools an organization uses to pursue its

objectives with respect to its target market
Classified into 4 broad group:
Product organization offering
Price what is given up or sacrificed to obtain a
product (consider cost function, competitors price and
the demand for the products)
Place distribution; activity to make product available
when and where the targeted customer want to buy it
Promotion inform, remind and persuade the target
market about an organization and its offerings;
members of target market to take action at specific
time

EXPECTATIONS,
SATISFACTION,
QUALITY,
Expectations are internal standards used by
the customers
when
evaluating product or
VALUE
AND
LOYALTY
service
Satisfication is a person feelings of pleasure
or disappointment resulting from comparing a
products perceived performance (or
outcome) in relation to his or her expectations
Quality is superiority or excellence
Value is the ratio between the perceived
benefits vs perceived costs
Loyalty

GENERIC STANDARDS
ISO 9001

Generic means that the same standards can

be applied:
to any organization, large or small,
whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department.
Generic also signifies that ; no matter what the
organization's scope of activity, if it wants to
establish a quality management system,
ISO 9001 gives the essential features

QUALITY MANAGEMENT
ISO

9001 is for quality management.

Quality refers to all those features of a product (or
service) which are required by the customer.
Quality management means what the organization
does to ensure that its products or services satisfy the
customer's quality requirements and
comply with any regulations applicable to those
products or services.
Quality

management also means what the

organization does to :
enhance customer satisfaction, and
achieve continual improvement of its
performance

MANAGEMENT SYSTEMS
Management

system means what the

organization does to manage its
processes, or activities in order that; its
products or services meet the
organizations objectives, such as
satisfying the customer's quality
requirements,
complying to regulations

MANAGEMENT SYSTEMS
To

be really efficient and effective, the organization can

manage its way of doing things by systemizing it.
Nothing important is left out.
Everyone is clear about who is responsible for
doing what, when, how, why and where.
Management system standards provide the organization
with an international, state-of-the-art model to follow.
Large organizations, or ones with complicated processes,
could not function well without management systems.
Companies in such fields as aerospace, automobiles,
defence, or health care devices have been operating
management systems for years.
The ISO 9001 management system standards now
make these successful practices available for all
organizations

PROCESSES, NOT
PRODUCTS
ISO

9001 concern the way an

organization goes about its
work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product
manufacturers and service
providers.

PROCESSES, NOT
PRODUCTS (CONT.)
Processes

affect final products

or services.
ISO 9001 gives the
requirements for what the
organization must do to manage
processes affecting quality of
its products and services

BUSINESS PROCESS CONTOH

Customer Satisfaction

MEETING THE
DEMAND

PRODUCTON PLANNNG
The purpose of the production planning is to ensure
that manufacturing run effectively and efficiently
and produces products as required by customers.

Production Planning:
Long-Range Capacity Planning

Entire
Product Line

Aggregate Planning

Product
Family

Master Production Scheduling

Specific
Product Model

Production Planning and Control Systems

Labor, Materials,
Machines

Proses Perencanaan Supply Chain

Material Requirement Planning
Component
Requirement

Supplier

Demand Forecasting

Demand Planning

Production
Plan

Plant

Warehouse

Logistics

Order Management

Retailer

INPUTS
A

forecast of demand covering the

selected planning horizon (e.g.6-12
months)
Marketing Order
Priority of Order
Starting material availability
The current status of the system in
terms of inventory level, production
rate, waiting time, warehouse
capacity

OUTPUTS
A

production plan: aggregate

decisions for each period in the
planning horizon about
inventory level
production rate

Projected

costs if the production

plan was implemented

TIPE MANUFAKTURING
Processes:

Batch

Paling umum digunakan

Jumlah terrencana dari sebuah produk
Banyak produk yang berbeda dibuat
menggunakan peralatan yang sama
Situasi ekonomi menetapkan ukuran batch
yang paling optimal
Produk dijalankan berdasarkan urutan logis
untuk mengoptimalkan proses
Lead time termasuk waktu tunggu dalam
antrian untuk di produksi dan waktu proses

TIPE MANUFAKTURING
Processes:

Flow

Tidak begitu umum

Produksi satu jenis produk saja
Variabilitas sangat rendah
Peralatan beroperasi pada kecepatan
yang tetap
Lead time pendek karena produk selalu
tersedia setiap saat
Kapasitas mahal dan sulit untuk
ditingkatkan

KAPASITAS MANUFACTURING
Biasanya

tetap pada kecepatan yang ditetapkan oleh

peralatan
Ekonomi mengatur kapasitas minimum untuk
memenuhi kebutuhan
Kelebihan kapasitas mengakomodasi variabilitas
Permintaan dapat melebihi kapasitas
Penambahan kapasitas biasanya memakan waktu yang
panjang

PROSES PERENCANAAN
MANUFAKTURING : MAKE-TOLead
time permintaan lebih pendek dibandingkan dengan
STOCK
lead time dari pasokan

Order diisi dari inventory

Mengunakan forecast untuk memproduksi inventory

sebelum adanya permintaan

Adalah penting untuk membuat forecast secara akurat

Jumlah penambahan didasarkan pada ukuran ekonomis

PROSES PERENCANAAN
MANUFAKTURING : MAKE-TOMenunggu order
ORDER
aktual sebelum

memproduksi

Lead time
permintaan lebih
lama dibandingkan
dengan lead time
pasokan

Biasanya untuk
item-item dengan
permintaan yang
rendah sehingga
sulit diperkirakan

PENTINGNYA FORECAST
PERMINTAAN
Forecast adalah

estimasi dari
permintaan yang
diantisipasi
Semua forecasts
mengandung error

Forecast error adalah

perbedaan dari forecast
dengan aktualnya

Tujuannya adalah untuk

mendapatkan forecast
error yang minimum
sehingga perencanaan
dapat diterima

SEJARAH JUST-IN-TIME
MANUFACTURING
1799 Eli Whitney, interchangeable parts

1910 Henry Ford, pertamakali menerapkan Just in Time

manufacturing
Kami menemukan bahwa adalah tidak bermanfaat bila kita
membeli selain yang dibutuhkan, Henry Ford.
Proses didesain untuk menghilangkan waste dan mengurangi
variabilitas

1950 Toyota memperkenalkan Sistem Produksi Toyota

Replikasi dari sistem Ford, termasuk konsep baru mengenai Total
Quality Management, Small Batch Production and Cellular
Manufacturing

1990 James Womack, Mesin yang mengubah dunia, Sejarah

pembuatan mobil di Japan, US and Europe diperkenalkan
Lean Manufacturing sebagai frase baru untuk JIT
Today Masih mengenai bagaimana menghilangkan waste
dalam proses bisnis secara total

KONSEP JUST-IN-TIME

Definisi : Memproduksi sejumlah yang dibutuhkan dan

ditransfer dimana dibutuhkan secara tepat dan pada saat
yang tepat Karakteristik:

Inventory kecil atau tidak ada sama sekali

Kebanyakan make-to-order dengan lead times yang pendek
Sangat mengurangi variabilitas dari semua sumber
Menghilangkan variabilitas dengan sebab khusus
Supply chain disinkronisasikan dengan proses dua arah (bolakbalik)
Banyak melibatkan jadwal yang ketat

Kelebihan kapasitas adalah bentuk waste yang

harus diminimalkan
Sistem JIT harus didesain dengan hati-hati
Membutuhkan waktu bertahun-tahun untuk mengembangkannya
Tidak terjadi secara natural atau tanpa sengaja

KEKURANGAN JIT UNTUK

SISTEM KESEHATAN PUBLIK
Permintaan

dikarakterisasi oleh kejadian-kejadian

yang kebanyakan tidak diharapkan
Persyaratan lead time dari end user sangat pendek
Kondisi stabil dari rantai pasokan tidak dapat
mengakomodasi saat-saat dimana kebutuhan
menjadi sangat tinggi
Tidaklah praktis untuk memiliki kapasitas yang
cukup untuk bisa mengakomodasi kebutuhan yang
tinggi
Kegawatdaruratan kesehatan publik tidak dapat
dijadwalkan sebelumnya
Untuk kegawatdaruratan kesehatan publik.. Kita
harus memiliki produk yang siap untuk dikirimkan

INVENTORY MANAGEMENT
Inventory-A

physical resource that a firm

holds in stock with the intent of selling it or
transforming it into a more valuable state.

Inventory

System- A set of policies and

controls that monitors levels of inventory
and determines what levels should be
maintained, when stock should be
replenished, and how large orders should
be

TYPES OF INVENTORES

Raw Materials

Works-in-Process

Finished Goods

Distribution Inventory

Supplies: Maintenance, Repair and Operating (MRO)

MANAGING FACILITATING
GOODS
Replenishment
order

Factory
Production
Delay

Replenishment Replenishment
order
order

Wholesaler

Distributor

Shipping
Delay
Wholesaler
Inventory

Retailer

Shipping
Delay
Distributor
Inventory

Customer
order

Customer

Item Withdrawn

Retailer
Inventory

Type of Inventory
Type of Organization

A. Retail systems
1. Sale of goods
2. Sale of services
B. Wholesale / Distribution
systems

Supplies

In-Process
Goods

Finished
Goods

*
*

C. Manufacturing systems
1. Special project
*
2. Intermittent process
.
3. Continuous process *

a. Process industries
b. Repetitive mfging.

Raw
Materials

*
*
*

*
*
*

Inadequate control of inventories can result

in both under- and overstocking of items.
Understocking (too few) results in missed
deliveries, lost sales, dissatisfied customers, and
production bottlenecks (idle workers or machines).
Resulting underage cost.
Overstocking (too many) ties up funds that might
be more productive elsewhere.
Resulting overage cost.
Goal: matching supply with demand!

REASONS FOR
INVENTORIES

Improve customer service

Economies of purchasing
Economies of production
Transportation savings
Hedge against future
Unplanned shocks (labor strikes, natural
disasters, surges in demand, etc.)
To maintain independence of supply chain

REASONS AGAINST
INVENTORY
Non-value

added costs
Opportunity cost
Complacency
Inventory deteriorates,
becomes obsolete, lost, stolen,
etc.

INVENTORY RELATED
COSTS
Procurement Costs:
Order processing
Shipping
Handling

Carrying (Holding) Costs

Capital (opportunity) costs

Inventory risk costs
Space costs
Inventory service costs

Out-of-Stock Costs
Lost sales cost
Back-order cost

INDEPENDENT AND
DEPENDENT DEMAND
Independent

demand items
are finished products or parts that
are shipped as end items to
customers.
Dependent demand items are
raw materials, component parts,
or subassemblies that are used to
produce a finished product.

INDEPENDENT VS.
DEPENDENT DEMAND
Independent Demand
(finished goods and spare parts)

Dependent Demand

(components)

C(2)

B(4)
D(2)

E(1)

D(3)

F(2)

OBJECTIVES OF INVENTORY
CONTROL

Maximize the level of

customer service by avoiding
understocking.
2) Promote efficiency in
production and purchasing by
minimizing the cost of
providing an adequate level of
customer service.
1)

BALANCE IN INVENTORY
LEVELS
When

should the company

replenish its inventory, or when
should the company place an
order or manufacture a new lot?
How much should the company
order or produce?
Next: Economic Order Quantity
(EOQ)

BALANCING CARRYING
AGAINST ORDERING COSTS
Annual Cost ($)
Higher

Minimum
Total Annual
Stocking Costs

Lower

Total Annual
Stocking Costs
Annual
Carrying Costs
Annual
Ordering Costs
Smaller

EOQ

Larger

Order Quantity

INVENTORY
CONSIDERATION
Customer
Lead

order/demand

time

Sources/location
(Local/Regional/National/Internatio
nal)
Quality checking time
Minimum

order quantity
Warehouse capacity

CLASSIFYING INVENTORY
ITEMS

ABC Classification (Pareto Principle)

A Items: very tight control, complete and
accurate records, frequent review
B Items: less tightly controlled, good
records, regular review
C Items: simplest controls possible,
minimal records, large inventories,
periodic review and reorder

ABC CLASSIFICATION
SYSTEM
Classifying
inventory according to

some measure of importance and

allocating control efforts accordingly.
A - very important
B - mod. important
C - least important

High

Annual
$ value
of items

B
C

Low
Low

High

Percentage of Items

ABC CLASSIFICATION
SYSTEM

VENDOR/SUPPLIER
SELECTION
Qualification

Reputation
Enough capacity
Assesed

and audited

VENDOR AUDIT
PENDAHULUAN (1)
Pertamakali

dikenal dalam industri

penerbangan, di akhir tahun 1950-an ; saat
itu menjadi sangat nyata bahwa pesawat
terbang tidak bisa dibuat kemudian
disertifikasi bahwa pesawat tersebut layak
untuk terbang hanya dengan melakukan
inspeksi pada pesawat tersebut saja.
Kualitas harus dibangun ke dalam setiap
pembuatan bagian dan setiap manual
pengoperasian.
Opini tidak lagi dapat diterima, instruksi
yang disetujui oleh perusahaan dan
terdokumentasi menjadi kebutuhan.

VENDOR AUDIT
PENDAHULUAN (2)
Lahirlah

Manajemen Kualitas, bukan

terjadi begitu saja tapi melalui sebuah
proses dan perubahan mindset.
Beberapa tahun kemudian, hal serupa
menjadi nyata untuk para regulator obat
sehingga muncullah cGMP
Inspeksi dan penilaian kualitas menjadi
sangatlah penting dan menilai supplier
menjadi satu kewajiban
Lahirlah dokumen seperti URS, RA, VP,
DQ, IQ, OQ, PQ

VENDOR AUDIT - TUJUAN

1.

2.

3.
4.

Memastikan reputasi dari perusahaan tersebut

(agar kontinuitas bahan yang dipasok dapat
terjaga)
Evaluasi kontraktor dan personnel dari
perusahaan tersebut terkait dengan kebijakan
etik.
- Menyelesaikan permasalahan
- Pemutusan hubungan bisnis
- Tindakan disipliner internal
Evaluasi prosedur pengendalian dan kepatuhan
perusahaan
Menjalin kerjasama dan komunikasi dengan
perusahaan tersebut agar terjadi pertukaran
informasi untuk keuntungan bersama

VENDOR AUDIT
Penilaian

terhadap pemasok

Bahan baku dan

Bahan kemas.

Standard

GMP untuk API

ISO 9001 - 2008

VENDOR AUDIT KEUNTUNGAN

Meningkatkan

kepercayaan
terhadap pemasok.
Mengantisipasi kemungkinan
penyimpangan yang mungkin dapat
terjadi pada proses pembuatan
Bahan baku dan
Bahan kemas
Bahan dari Pemasok Terkualifikasi

IMPLEMENTASI VENDOR
AUDIT
Overseas Manufacturer
Questionnaire
Local

Manufacturer

Audit/inspeksi di tempat

LINGKUP VENDOR AUDIT

Questionnaire penilaian kualitas harus mencakup hal sbb :

Umum
Organisasi dan personnel.
Fasilitas
Peralatan
Integrasi sistem
Rencana pengembangan
Rencana pengujian

Manajemen Konfigurasi
Dukungan Pelanggan
Pengamanan Produk
Pengendalian Perubahan
Sistem kualitas
Pengendalian dokumen
Dokumentasi program
Manajemen dokumen

(namun harus ada metode untuk memberikan pembobotan

pada topik-topik tersebut agar hanya topik yang kritikal
saja yang memberikan dampak yg signifikan pada hasil
penilaian kualitas)

Customer Satisfaction

CONTINUAL
IMPROVEMENT

COMPLAINT HANDLING
Principle
All complaints and other
information concerning potentially
defective products must be
carefully reviewed according to
written procedures and corrective
action should be taken.
Investigate

COMPLAINTS PROCEDURE
Designated responsible person:
To handle complaint
Decide on measure to be taken
May be authorized person - if not, must advise authorized
person of results
Sufficient support staf
Access to records
Written procedure (SOP):
Describes action to be taken
Includes need to consider a recall (e.g. possible product
defect

Thorough investigation:
QC involved
With special attention to establish whether "counterfeiting"
may have been the cause
Fully recorded investigation reflect all the details

Due to product defect (discovered or suspected):

Consider checking other batches
Batches containing reprocessed product

COMPLAINTS PROCEDURE

Investigation and evaluation should result in

appropriate follow-up actions
May include a "recall"

All decisions and measures taken should be recorded

Referenced in batch records

Records reviewed - trends and recurring problems

Classification of Defects

If complaint is justified, then there has been a failure of the

quality system

Once defect has been identified, company should be

dealing with it in an appropriate way, even recall

The definition of defects is useful

The following system has been found in some countries (but

it is not a WHO guideline):
Critical defects
Major defects
Other defects

COMPLAINTS
Critical Defects

Those defects which can be life-threatening and require the

company to take immediate action by all reasonable means,
whether in or out of business hours

Examples

Product labelled with incorrect name or incorrect

strength
Counterfeit or deliberately tampered-with product
Microbiological contamination of a sterile product

COMPLAINTS
Major Defects

Those defects which may put the patient at some risk but
are not life-threatening and will require the batch recall or
product withdrawal within a few days

Examples
Any labelling/leaflet misinformation (or lack of
information) which represents a significant hazard to the
patient
Microbial contamination of non-sterile products with
some risk for patients
Non-compliance to specifications (e.g. active ingredient
assay)

COMPLAINTS
Other Defects

Those defects which present only a minor risk to the

patient batch recall or product withdrawal would
normally be initiated within a few days

Examples

Readily visible isolated packaging/closure

faults
Contamination which may cause spoilage or
dirt and where there is minimal risk to the
patient