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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14
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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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