GOOD DISTRIBUTION PRACTICE

as one of the KEY elements for

Quality of Medicinal Products

Muhammad Lukmani Ibrahim

National Pharmaceutical Control Bureau
Ministry of Health
Malaysia

Introduction
Distribution
Good Distribution Practice (GDP)
GDP in Malaysia

INTRODUCTION TO THE LICENSING

ACTIVITIES IN MALAYSIA
The Control of Drugs & Cosmetics Regulations
1984 empower the Drug Control Authority (DCA),
Ministry of Health to implement the Registration
of Products and the Licensing of Premises
(Manufacturers, Importers , Wholesalers)
However , the activities are carried out by the
National Pharmaceutical Control Bureau
which serves as the Secretariat of the DCA

INTRODUCTION TO THE LICENSING

ACTIVITIES IN MALAYSIA
Regulation 7(1)
All products must be registered &
possess appropriate license

REGULATORY CONCERNS

Special storage
needs e.g
Temperature
sensitivity

Regulation 12 (1)
Types of licenses (Manufacturer,
Import, CTIL, Wholesale)
Regulation 12 (4)
Validity of license

Counterfeit

Regulation 13 (1)
Processing fees
Regulation 14 & 17
The power of authority

More variety
in distribution
mode

Information
on the
progress of the
transport is
not very
transparent

NPCB

Origin cannot
be confirmed /
false origin e.g
internet sales
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DISTRIBUTION
DEFINITION
The division and movement of pharmaceutical
products from the premises of the manufacturer of
such products or another central point, to the end
user thereof or to an intermediate point by means
of various transport methods, via various storage
and/or health establishments
WHO (Working Document QAS/08.252, January 2008)

(Overseas)

Distribution chain
in Malaysia

DISTRIBUTION

Licensed
Manufacturer

(where distribution begins)

Distribution

Forms an important activity of the integrated

supply chain management of medicinal products.
Various persons and entities are often responsible
for the handling, storage and distribution of such
product
The quality of medicinal products can be affected
by a lack of adequate control over numerous
activities which occur during the distribution
process
The storage, trade and distribution of medicinal
products are activities that are carried out by
various companies, institutions and individuals

Entry Point
(Local)
Licensed
Manufacturer

Repack

Licensed
Importer

Distribution

Distribution

Distribution

Distribution

Licensed Wholesaler

Distribution

Clinic

Hospital

Pharmacy

GMP VS DISTRIBUTION

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GMP VS DISTRIBUTION

The nature of the risks involved may generally,

however, be the same as those in the
manufacturing environment e.g mix-ups,
contamination and cross contamination
There are thus aspects in distribution to which
the principles of Good Manufacturing Practice
(GMP) should be applied
These include, but are not limited to, storage,
distribution, transportation, packaging, labeling,
documentation and record-keeping practices.
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Distribution is included within the definition

of manufacture in the PIC/S Guidelines
Chapter 1
requires satisfactory arrangements for storage and
distribution to maintain quality
Chapter 4
requires batch distribution records to be kept
Chapter 5
deals with storage after release and the handling of
product returned from the market
Chapter 8
deals with product complaints and recalls
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GOOD MANUFACTURING PRACTICE

To maintain the original quality, every
activity in the distribution of medicinal
products should be carried out according
to the principles of GMP,GSP and GDP

GDP

PRODUCT
QUALITY

GMP is that part of Quality Assurance which

ensures that products are consistently
produced and controlled to the quality
standards appropriate to their intended use
and as required by the marketing
authorization or product specification

GSP

GMP
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GOOD STORAGE PRACTICE

The special measures that need to be considered in the
storage, transportation and distribution of registered
products, such that the registered product will be of the
nature and quality intended when it reaches the
consumer
Guidelines on Good Storage Practice (GSP),2nd Edition, 2004

That part of quality assurance that ensures that the quality of

pharmaceutical products is maintained by means of
adequate control throughout the storage thereof
WHO (Working Document QAS/08.252, January 2008)

GOOD DISTRIBUTION PRACTICE

THE IMPORTANCE OF GDP

Good Distribution Practice (GDP) is that part of

quality assurance which ensures that products are
consistently stored, transported and handled under
suitable condition as required by the marketing
authorization (MA) or product specification
- MHRA, UK -

A quality system to ensure that medicinal products

are procured, stored, transported, distributed and
handled systematically and in an appropriate
manner.

To ensure that the quality

of medicinal products are
maintained throughout
the distribution network
Preservation of product quality
down supply chain from
manufacturer to distributors
and eventually to retailers
/consumers

GDP
Quality

GDP

- HSA, SINGAPORE 17

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THE IMPORTANCE OF GDP

THE IMPORTANCE OF GDP

Prevention of the
occurrence of mix-up
and crosscontamination

Traceability
To facilitate
investigation and
effective recall of faulty
products

To ensure the correct

product is delivered to
the correct addressee
within a satisfactory
time period
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EXAMPLE OF GDP ISSUES

VARIOUS GDP GUIDELINES

Injectable products were not stored under the

appropriate storage conditions so that their
original quality is not affected upon transportation
Details
Ice packs were placed together with the
injectable products during transportation
to keep the temperature down. However,
the manufacturer failed to prove that the
temperature is within the specified storage
condition as no temperature monitoring
was conducted. Furthermore, temperature
indicator
was
not
used
during
transportation.

HSA

WHO

Personnel
Premises and facilities
Stock handling and stock control
Disposal of products
Documentation system
Product complaints
Product recall
Returned material
Counterfeit products
Self inspection
Contract acttivities
Handling of API or intermediates

Organization and management

Personnel
Quality Management
Premises, warehousing and storage
Vehicles and equipment
Shipment containers and container labelling
Distribution
Transportation and products in transit
Documentation
Repackaging and relabelling
Complaints
Recalls
Returned products
Counterfeit pharmaceutical products
Importation
Contract activities
Self inspection

EMEA
Personnel
Documentation
Premises and equipment
Deliveries to customers
Returns
Self inspection
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GDP IN MALAYSIA
GDP in Malaysia is currently conducted by adopting the GSP
Guidelines
(Guidelines on Good Storage Practice (GSP),2nd Edition, 2004 )

PART ONE
Personnel
Premises and facilities
Stock handling and stock control
Disposal of pharmaceutical products
Documentation

PART TWO
Product complaints
Product recall

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PROGRESS .. MALAYSIA

CHALLENGES TO FACE
With regulators

Working group on the establishment of

GDP Guidelines (incorporating current
GSP Guidelines)
Comparison of GDP guidelines that are
available

No forum for information

exchange
Lack of harmonization of
GDP standards
The obsolescence of the
respective GDP Guidelines
Control points for transport

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CHALLENGES TO FACE

REFERENCE

With industries

1.

WHO (Working Document QAS/08.252,

January 2008)
2. EMEA, Guidelines on Good Distribution
Practice of Medicinal Products for Human
Use,1992.
3. HSA, Guidance Notes on Good Distribution
Practices,Guide-MQA-013-005,2005

Commitment by the parties

involved i.e wholesalers /
distributors /transporters
Inadequate understanding
and exposure on GDP to the
industry
Unwillingness to invest
Counterfeits and adulteration

4.

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Guidelines on Good Storage Practice (GSP),2nd

Edition, 2004

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Thank you
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