Good distribution

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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

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Introduction
Distribution
Good Distribution Practice (GDP)
GDP in Malaysia

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INTRODUCTION TO THE LICENSING
ACTIVITIES IN MALAYSIA
However , the activities are carried out by the
National Pharmaceutical Control Bureau
which serves as the Secretariat of the DCA
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)

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Regulation 7(1)
All products must be registered &
possess appropriate license
Regulation 12 (1)
Types of licenses (Manufacturer,
Import, CTIL, Wholesale)
Regulation 12 (4)
Validity of license
Regulation 13 (1)
Processing fees
Regulation 14 & 17
The power of authority
INTRODUCTION TO THE LICENSING
ACTIVITIES IN MALAYSIA

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REGULATORY CONCERNS
More variety
in distribution
mode
Information
on the
progress of the
transport is
not very
transparent
Counterfeit
Special storage
needs e.g
Temperature
sensitivity
Origin cannot
be confirmed /
false origin e.g
internet sales
NPCB

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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)
DISTRIBUTION

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• 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
DISTRIBUTION

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Licensed
Manufacturer
Licensed
Manufacturer
Licensed
Importer
Licensed Wholesaler
Hospital
(Local)
Entry Point
(Overseas)
Pharmacy
Clinic
Distribution chain
in Malaysia
(where distribution begins)
Repack
Distribution
Distribution
Distribution
Distribution
Distribution
Distribution

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• 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.
GMP VS DISTRIBUTION

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 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
GMP VS DISTRIBUTION
Distribution is included within the definition
of manufacture in the PIC/S Guidelines

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PRODUCT
QUALITY
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
GMP
GDP GSP

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GOOD MANUFACTURING PRACTICE
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

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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)

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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.
- HSA, SINGAPORE -
GOOD DISTRIBUTION PRACTICE

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• 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
THE IMPORTANCE OF GDP

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• Traceability
To facilitate
investigation and
effective recall of faulty
products
THE IMPORTANCE OF GDP

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• Prevention of the
occurrence of mix-up
and cross-
contamination
• To ensure the correct
product is delivered to
the correct addressee
within a satisfactory
time period
THE IMPORTANCE OF GDP

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Injectable products were not stored under the
appropriate storage conditions so that their
original quality is not affected upon transportation
EXAMPLE OF GDP ISSUES
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.

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WHO
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
HSA
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
EMEA
Personnel
Documentation
Premises and equipment
Deliveries to customers
Returns
Self inspection
VARIOUS GDP GUIDELINES

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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
GDP IN MALAYSIA

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• Working group on the establishment of
GDP Guidelines (incorporating current
GSP Guidelines)
• Comparison of GDP guidelines that are
available
PROGRESS .. MALAYSIA

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• No forum for information
exchange
• Lack of harmonization of
GDP standards
• The obsolescence of the
respective GDP Guidelines
• Control points for transport
CHALLENGES TO FACE
With regulators

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• 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
CHALLENGES TO FACE
With industries

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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
4. Guidelines on Good Storage Practice (GSP),2nd
Edition, 2004
REFERENCE

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Thank you

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