Amalan Pengedaran Baik Bagi Produk Rangkaian Sejuk

GOOD DISTRIBUTION PRACTICE (GDP) SECTION
CENTRE OF COMPLIANCE & QUALITY CONTROL

NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA)
MINISTRY OF HEALTH MALAYSIA
AMALAN PENGEDARAN BAIK

BAGI PRODUK RANGKAIAN SEJUK

1
OUTLINE
1. Legislation
2. Introduction: GDP Section, Centre for Compliance and Quality
Control, NPRA
3. GDP in Malaysia: Guideline on GDP, 3rd Edition, 2018
2
LEGISLATION
Malaysian Laws On Poisons and Sale of Drugs
• Dangerous Drug Act 1952 (revised 1980)

• Poisons Act 1952 (Act 366) & regulations
• Sale of Drugs Act 1952 (Act 368)
• Control of Drugs and Cosmetics Regulations 1984
• Registration of Pharmacists Act 1951 (Act 371) & regulations
• Medicines (Advertisement and Sale) Act 1956 (Act 290) & regulations
3
LEGISLATION
Control of Drugs and Cosmetics Regulations 1984
Regulation 7(1)
No person shall manufacture, sell, supply, import, possess or administer any

product
unless:
(a) the product is a registered product,
and
(b) the person holds the appropriate license required & issued under these
Regulations.
4
LEGISLATION
Control of Drugs and Cosmetics Regulations 1984
Regulation 12 of CDCR 1984: Licenses
(1) The Director of Pharmaceutical Services may, subject to the provisions of these Regulations,
issue any of the following licences subject to such conditions as he may impose:
(a) a manufacturer's licence in Form 2 in the Schedule, authorising the licensee to
manufacture the registered products in the premises specified in the licence and to sell by
wholesale or supply the products;
(b) a wholesaler's licence in Form 3 in the Schedule, authorising the licensee to sell by
wholesale or supply the registered products from the address of the business premises
specified in the licence;
(c) a clinical trial import licence in Form 4 in the Schedule, authorising the licensee to import
any product for purposes of clinical trials, notwithstanding that the product is not a registered
product;
(d) an import licence in Form 5 in the Schedule, authorising the licensee to import and sell by
wholesale or supply the registered products from the address of the premises specified in
the licence.
5
LEGISLATION
Directive
Efektif : 01 Januari 2012
• Arahan Pematuhan Terhadap Keperluan Garis

Panduan Amalan Pengedaran Baik (AEB)
• Melibatkan pemegang Lesen Pengilang, Lesen

Mengimport dan Lesen Pemborong Produk
Berdaftar/Kosmetik Bernotifikasi
• Pemeriksaan AEB dijalankan oleh NPRA dan

Cawangan Penguatkuasaan Farmasi Negeri
(CPFN)
6
INTRODUCTION
7
INTRODUCTION
Menyelaras dan menjalankan aktiviti berkenaan pemeriksaan Amalan Pengedaran
Baik (AEB) dan pemeriksaan Fasiliti Rangkaian Sejuk bagi pengimport/pemborong
produk/kosmetik
Menyemak dan menilai laporan ‘Corrective Action & Preventive Action (CAPA)’ bagi
GDP Section pemeriksaan AEB dan Fasiliti Rangkaian Sejuk
Mengurus dan menyemak aktiviti pelaporan pemeriksaan yang dijalankan oleh

PKKK dan CPFN
Menyelaras sebarang aktiviti berkaitan dengan pembangunan industri seperti

pelaksanaan latihan dan khidmat nasihat kepada jabatan-jabatan / agensi-agensi
kerajaan/CPFN dan industri.
Menyelaras dan mengkaji perkara berkaitan polisi, dasar, praktis semasa serta
sebarang hal/aktiviti berkenaan AEB melibatkan pengimport/pemborong
produk/kosmetik di Malaysia.
8
GDP GUIDELINE
GDP in Malaysia
2011 2012 2018 - kini
2013 - 2017
1st Edition GDP Guideline
1995 – 2010 Published
Implementation
N.B. These notes are to be read alongside with

the Guideline
9
Rangkaian Bekalan Pengilang (Luar negara)
Produk Berdaftar/Kosmetik Berlesen
Pengedaran
Bernotifikasi
Pintu masuk
Pengedaran
(Tempatan)
Pengilang Pembungkusan
Berlesen Semula
Pengimport
Berlesen
Pengedaran
Pengedaran Pengedaran
Pengedaran Pengedaran
Pemborong
Berlesen
Pengedaran
Pengedaran
Pengedaran
Hospital/ Pasaraya/Kedai
Ubat Farmasi
Klinik
10
GDP GUIDELINE
THIS GUIDELINE is applicable:
To all organisations and individuals involved in any aspect of the storage and distribution of products/cosmetics
including but not limited to the following:
 Manufacturers - active pharmaceutical ingredients, packaging materials, drug

products, involved in packaging/repackaging operations
 Importers
 Wholesale distributors, distribution organisations involved in road, rail, sea
and/or air services
 Third-party and freight forwarders
 Pharmacies, including but not limited to retail, compounding and hospital

 Health care professionals storing products prior to dispensing or
administering to patients
11
GDP GUIDELINE
Definition of Good Distribution Practice

“The measures that need to be considered in the storage,
transportation and distribution of any registered
product/cosmetic and its related materials such that the
nature and quality intended is preserved when it reaches
the consumer”
12
GDP GUIDELINE
Definition of Time and Temperature Sensitive Product

(TTSP)
“Any good or product which, when not stored or

transported within predefined environmental conditions
and / or within predefined time limits, is degraded to the
extent that it not longer performs as originally intended”
13
GDP GUIDELINE
ORGANIZATION OF GDP GUIDELINE

Introduction : 1
Chapter : 11
Annex : 2
14
CENTRE OF COMPLIANCE & QUALITY CONTROL CHAPTER 1:
MINISTRY OF HEALTH MALAYSIA QUALITY SYSTEM
The quality system is the responsibility of the organisation’s management and requires
A quality system their leadership and active participation and should be supported by personnel
setting out commitment.
responsibilities,
processes and risk All critical steps of the processes and significant changes should be justified, manage under
established change control system and where relevant validated
management
principles in relation
to the activities of All relevant activities should be clearly defined in procedures and systemically reviewed
importation,
procurement, Documentation to permit traceability of the products/cosmetics throughout distribution
storage, channel
transportation and Quality system should extend to the control and review of any outsourced activities
distribution of
products/cosmetics Ensure appropriate products/cosmetics are sourced from approved suppliers and
should be maintained distributed by approved entities
15
MINISTRY OF HEALTH MALAYSIA PERSONNEL
Organization chart
- - adequate number of competent personnel
- depend on the volume and scope of activities
Job description
- define authority and responsibilities
- no gaps or unexplained overlaps in the responsibilities
Training
- appropriate to the duties
- documented training program and records
- training effectiveness assessed
Hygiene and Clothing

- appropriate, adequate and relevant to the activities being carried out
16
MINISTRY OF HEALTH MALAYSIA PREMISES AND EQUIPMENT
• Adequate lighting and • Written sanitation
Sanitation Programme and Pest Control

Requirement on facilities and storage
• Permanent address
Requirements on building
ventilation programme and

• Sufficient security • Clean and free from procedures for
• Protection from accumulated premise/storage
contamination/weather waste/dust area/spillage
and deterioration by • Adequate storage areas • Cleaning record
light, moisture, to allow storage of maintained
temperature various categories of • Written programme for
• Receiving and products/cosmetics: pest control and
dispatched area quarantine and appropriate record
appropriately designed released, rejected,
• Rest, wash and returned or recalled
refreshment rooms
should be adequately
separated from the
storage area
17
MINISTRY OF HEALTH MALAYSIA PREMISES AND EQUIPMENT
• All equipment • Secured and protected
Maintenance and calibration
Computer system
Temperature and Environment Control
• Equipment and impacting on storage against

procedures to check the and distribution should accidental/unauthorised
environment be designed, located, modifications
• Temperature mapping
maintained and • Regularly backed up
cleaned to a standard
exercise which suits its intended
purpose
• Planned maintenance,
procedures and
records of operations,
repair, maintenance
and calibration
18
References
Technical Supplements to WHO Technical Report Series, No.

961, 2011
Annex 9: Model guidance for the storage and transport of time-
and temperature-sensitive pharmaceutical products
19
• Continuous temperature monitoring and/or humidity monitoring
• Fitted with an alarm system
• Alternative power supply and contingency plan
20
Qualification applied to temperature-controlled
storage
• Temperature-controlled storage covers any area where TTSP have
to be stored within a controlled temperature range (e.g. 2.0°C to 8.0°C
or 15.0°C to 25.0°C)
• This includes:
- active temperature-controlled storage equipment, including ultra-low
freezers, freezers, freezer rooms, refrigerators, cold rooms and
controlled-ambient stores
- actively temperature-controlled transport equipment, including
refrigerated and temperature-controlled trucks and vans
- temperature-controlled packaging systems, including active and
passive shipping containers
21
storage
• Qualification is an inspection and testing process used to
establish that a piece of equipment or a physical installation is
fit for purpose in the operational context within which it will be
used
• Consists of four sequential phases:

- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
22
storage
23
storage
• DQ
• Ensure that the premises, supporting utilities, equipment and
processes have been designed in accordance with the relevant
requirements (user requirements and regulatory requirements)
• IQ
• Ensure that the premises, supporting utilities and equipment have been
built and installed in compliance with their design specifications
24
storage
• OQ
• Provides assurance that the premises, supporting utilities and equipment and
processes operate in accordance with their design specification
• OQ is carried out on equipment when it is empty
• PQ
• Provides additional assurance through further testing that a specific process
will consistently produce a product meeting its predetermined specifications
and quality attributes.
• PQ is carried out on equipment that is loaded with product
• Outcome: Formal confirmation that the equipment, associated systems and
operational processes can be ‘released’ for routine use.
25
storage equipment
General • Qualification protocol
• Qualification report
OQ • Verify SOP/work instructions
• Verify all measuring devices (controller/sensors/EDLMs) have valid
calibration certificates and tagged (ID, calibration date, due date)
• Control panel test and check
• Alarm system test and check (High, Low, event, SMS, telephone, etc.)
• Carry out a temperature mapping of the empty storage area and record
• Conduct power failure test and check (holdover time, time taken to
recover within range)
PQ • Check that all controllers and sensors are correctly calibrated
• Carry out a temperature mapping of the storage area loaded as in
normal operations
• Temperature recovery following a door opening during normal
operation test and record 26
packaging systems
General • Qualification protocol
• Qualification report
• DQ & OQ may not be required when a prequalified shipping system is
used
• Maximum load and minimum loads are tested at each stage
OQ • Under lab condition, 3 x testings
• Transport duration
• Acceptable temperature range
• Payload details
• Ambient temperature profiles (heat, cold)
• Location of temperature monitoring devices
• Location of refrigerant (+specification)
• Transport and stress tests (vibration and drop)
PQ • Field test in real operating environment, 3 x testings
• Criteria should be similar to those defined in the DQ and OQ 27
storage
• Small-scale equipment (e.g. freezers, refrigerators)
- Still need qualification
- Some form of temperature mapping (include top, bottom,
front, rear location)
- Door shelves should not to be used to store TTSP
28
Temperature mapping of temperature-controlled
storage
• A temperature-mapping exercise is required for any space
allocated for the storage and handling of products with a
specified labelled storage temperature.
• Establish the temperature distribution within the zone being
mapped and locates hot and cold spots
29
Temperature mapping of temperature-controlled
storage
4 stages 10 steps
• Prepare a mapping protocol 1. Select EDLMs
2. Designate mapping team
• Carry out the mapping
3. Survey the site
exercise
4. Establish acceptance criteria
• Prepare a mapping report 5. Determine EDLM locations
• Implement the 6. Record EDLM locations
recommendations by carrying 7. Label and program the EDLMs
out the remedial and other 8. Fix EDLMs in position
actions identified in the 9. Conduct the mapping exercise
mapping report 10. Data collection and analysis
30
NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA) STOCK HANDLING AND STOCK CONTROL
Receiving Stock rotation and Returned and rejected Distribution Disposal

• Checked against control • Quarantined, clearly • Only after receipt of a • Appropriately
documentation • Periodically marked, stored in sales order identified, segregated
• Physical verification comparing the actual restricted area • Correctly picked with and handled
against label and recorded • Fate of returned appropriate accordingly
• Physical inspection quantity /rejected products remaining shelf life • Disposal records
for tampering, • Stock discrepancies determined after • System to permit its maintained for a
contamination, should be sufficient evaluation recall defined period
damage investigated • Returned to saleable • Deliveries made only
• Products remain in • Checked regularly for stock should be to wholesale dealers
quarantine status principle of stock placed such that the or persons who are
until a given written rotation, damage and stock rotation system authorised to supply
release/rejected is expired products operates effectively the products
issued
Procedures and records maintained
31
MINISTRY OF HEALTH MALAYSIA TRANSPORTATION
Transport/vehicle/containers used:
Procedures/documents in place:
Operation, cleaning, pest control program, Protect against spillage, Ensure temperature
maintenance and safety precautions of breakage, adulteration, conditions are maintained
vehicles misappropriation and theft within acceptable limits
That can be used to permit traceability

of product throughout the distribution
activities Suitable for use,
appropriately equipped to
Be of sufficient capacity to
protect stability and
allow orderly storage
Investigating and dealing with excursion integrity, to prevent
of storage requirements contamination
Where transportation is performed by a third

party (i.e. contract) Clean, free from
accumulated waste and
pests
32
• TTSP should be clearly labelled and identifiable from other products
in the same delivery
• If reusable cooling materials are to be used: procedures and records
must be in place
• Delivery route planning for TTSP
33
MINISTRY OF HEALTH MALAYSIA PRODUCTS/COSMETICS COMPLAINTS
Complaints
Recorded with all the original details
Distinction between quality related and distribution related
Thoroughly investigated to identify the origin of or the reason for the
complaint
Procedures
• Handling of all written and oral complaints
• Ensure complaints received are investigated and followed through
corrective actions to prevent repeated complaints
• Response to complainant after completion of the investigation
• Designated person to handle complaint - have the authority to initiate
investigations and decide measures to be taken
• Contact details of the designated/appointed person
34
MINISTRY OF HEALTH MALAYSIA PRODUCTS/COSMETICS RECALLS
Product Recall
- Process to remove/withdraw a particular products/cosmetics from all links of distribution
- Due to critical quality defects discovered or serious adverse drug reactions reported which might cause health risks to users
- Unless the Director of Pharmaceutical Services, Ministry of Health has already specified the degree and level of a particular
recall, the degree and level will be decided by the company’s Product Recall Committee based on risks involved.
• Products/Cosmetics with major health risks

Degree of Level of recall
that might caused serious injuries or death
recall Degree I • Should be under an embargo within 24 hours Level A: To all - nature of problem
- severity of consumers (end users) - extent of the
quality product/cosmetic’
defects and s distribution
adverse • Products/Cosmetics with minor health risks or Level B: To all points of - degree of hazard
reactions of are substandard sales (e.g. hospitals, involved
the Degree II • Should be under an embargo within 72 hours pharmacies, clinics,
specialists centres)
products/co
smetics
• Products/Cosmetics with other reasons for
recall Level C : To all sub-
distributors (wholesalers)
• Should be under an embargo within 30 days or
Degree III as specified
35
MINISTRY OF HEALTH MALAYSIA PRODUCTS/COSMETICS RECALLS
Procedures
• Handling of recalls in step wise manner
• reviewed and updated regularly
• Designated person/committee for the co-
ordination and execution of all product recalls
• Contact details of the designated person
committee
• Recall notification to all end users and
regulatory authority
• storage condition of recalled products/cosmetics
• final report on the progress of recall process
36
GOOD DISTRIBUTION PRACTICE (GDP) SECTION CHAPTER 8:
SUBSTANDARD AND FALSIFIED
MINISTRY OF HEALTH MALAYSIA PRODUCTS/COSMETICS
Procedure:
- Handling
Clearly labelled
- Investigation
- Decision on removal from market
- Disposal
Substandard
and Falsified
Physically Sale and distribution

segregated immediately suspended
37
MINISTRY OF HEALTH MALAYSIA OUTSOURCED ACTIVITIES
Outsourced Activities
- Activities performed and delegated to another party – correctly defined, agreed and controlled
Contract Contract
Giver Have adequate premises and
Acceptor
equipment, procedures, knowledge,
Assessing the experience and competent
competency of the CA personnel to carry out the work
to successfully carry out
the activity required
Do not pass to a third party any of
the work entrusted to him under the
contract
Ensuring adherence
through audits Might subject to inspection by the
RA
Duties Written contract Duties
38
MINISTRY OF HEALTH MALAYSIA SELF-INSPECTION
Evaluation of the
inspection report, and
Independent corrective actions by
and detailed management
way by a
Covering all designated,
aspects of GDP
and compliance competent
with the person
To trigger regulations,
necessary guidelines and
procedures
corrective
and
preventive
To monitor
implementation measures
and compliance
with the GDP
principles
39
GOOD DISTRIBUTION PRACTICE (GDP) SECTION CHAPTER 11:
MANAGEMENT OF DOCUMENTATION
MINISTRY OF HEALTH MALAYSIA AND RECORDS
Documents : Records :
Approved, dated and signed by Made at the time each operation is taken –
authorised persons activities/events are traceable
Clear, accurate and readily available
Clear, concise, comprehensible and Electronic record : access control ,
readily available protected (regular back-up)
Numbered, dated, have a title, name Kept, maintained and retained in

and position of the person responsible accordance with national, legislative
for the documents requirements
Include detailed instruction on the Hologram usage, MSDS, CoA

subject and a date of review
All relevant legal records and documentations should

comply to the current legislation
40
THANK YOU
For further information, kindly contact officers

from GDP Section at:
saeb@npra.gov.my or 03-7883 5491
41

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GOOD DISTRIBUTION PRACTICE (GDP) SECTION

CENTRE OF COMPLIANCE & QUALITY CONTROL

AMALAN PENGEDARAN BAIK

GOOD DISTRIBUTION PRACTICE (GDP) SECTION

Malaysian Laws On Poisons and Sale of Drugs

• Dangerous Drug Act 1952 (revised 1980)

No person shall manufacture, sell, supply, import, possess or administer any

(a) the product is a registered product,

• Arahan Pematuhan Terhadap Keperluan Garis

• Melibatkan pemegang Lesen Pengilang, Lesen

• Pemeriksaan AEB dijalankan oleh NPRA dan

Mengurus dan menyemak aktiviti pelaporan pemeriksaan yang dijalankan oleh

Menyelaras sebarang aktiviti berkaitan dengan pembangunan industri seperti

N.B. These notes are to be read alongside with

 Manufacturers - active pharmaceutical ingredients, packaging materials, drug

 Third-party and freight forwarders

 Pharmacies, including but not limited to retail, compounding and hospital

Definition of Good Distribution Practice

Definition of Time and Temperature Sensitive Product

“Any good or product which, when not stored or

ORGANIZATION OF GDP GUIDELINE

Hygiene and Clothing

• Adequate lighting and • Written sanitation

Sanitation Programme and Pest Control

ventilation programme and

• All equipment • Secured and protected

Maintenance and calibration

• Equipment and impacting on storage against

Technical Supplements to WHO Technical Report Series, No.

• Consists of four sequential phases:

Receiving Stock rotation and Returned and rejected Distribution Disposal

That can be used to permit traceability

Where transportation is performed by a third

• Products/Cosmetics with major health risks

Physically Sale and distribution

Duties Written contract Duties

Numbered, dated, have a title, name Kept, maintained and retained in

Include detailed instruction on the Hologram usage, MSDS, CoA

All relevant legal records and documentations should

For further information, kindly contact officers

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