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GMP Cosmetic in Malaysia: The Past &...
Transcript of GMP Cosmetic in Malaysia: The Past &...
GMP Cosmetic in Malaysia:
The Past & Present
MUHAMMAD LUKMANI IBRAHIM
Deputy Director of Regulatory Pharmacy
Head of Centre for Compliance And Licensing
National Pharmaceutical Regulatory Agency
Ministry Of Health Malaysia
OUTLINE
LAW & REGULATIONS : CONTROL OF COSMETICS IN MALAYSIA
GMP & GDP GUIDELINES
COMMON GMP FINDINGS & PUNITIVE ACTION AGAINST NON COMPLIANCE
GMP DIRECTIVES/CIRCULARS
INITIATIVE TO ASSIST INDUSTRY
FUTURE
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Law & Regulations : Control of Cosmetics in Malaysia
FROM REGISTRATION TO SELF REGULATION
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CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984
PART III A - NOTIFICATION OF COSMETICS
Regulation 18A. Prohibition to manufacture,
sell, supply, import, possess or administer
cosmetic.
(1) No person shall manufacture, sell, supply,
import, possess or administer any cosmetic—
(a) unless the cosmetic is a notified cosmetic;
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PART IV - MANUFACTURE OF REGISTERED
PRODUCTS OR NOTIFIED COSMETICS
•Regulation 19. Personnel
•Regulation 20. Premises
•Regulation 21. Equipment
•Regulation 22. Manufacturing operations
•Regulation 23. Quality control department
CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984
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Offence under:
Regulation1 8A, Control of Drug and Cosmetic Regulation 1984.
General Penalty:
Section 12(1) Sales of Drug Act 1952 -
(1) Subject to subsection (2), any person who commits an offence
against this Act or any regulation made under this Act for which
no penalty is expressly provided shall be liable on conviction to a
fine not exceeding twenty-five thuosand ringgit or to
imprisonment for a term not exceeding three years or to both,
and for a second or subsequent offence he shall be liable on
conviction to a fine not exceeding fifty thousand ringgit or to
imprisonment for a term not exceeding five years or to both.
UNNOTIFIED COSMETIC
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CONTROL OF COSMETICS IN MALAYSIA
Cosmetic Notification Holder is responsible to
ensure that :
Manufacturer (and assembler, where applicable)
of the cosmetic product is
compliant to Cosmetic Good Manufacturing
Practice
Reference:
Guidelines for Control of Cosmetic Products in Malaysia February 2017 (First Revision)
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• Manufacturer
A manufacturer is a company which is engaged in any process carried out in
the course of making the cosmetic products. The manufacturing process
includes all operations of purchase of starting materials, bulk intermediates
and products, formulation and production (such as grinding, mixing,
encapsulation and/or packaging), quality control, release, storage and
distribution of cosmetic products and the related controls.
• Primary Assembler
A primary assembler is a company which is engaged in a process of enclosing
the product in a primary/intermediate container which is labelled or to be
labelled before the product is sold or supplied in it.
• Secondary Assembler
A secondary assembler is a company which is engaged only in a process of
labelling the product container where the product is already enclosed in its
primary container and/or packing the product which is already enclosed in its
labelled primary container into a carton which is labelled or to be labelled,
before the product is sold or supplied.
CONTROL OF COSMETICS IN MALAYSIA
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1995• First draft based on pharmaceutical guideline
1997
• Joint drafting committee- NPCB and representatives from cosmetic industry.
2004• Malaysian GMP Cosmetic Guideline
2008
• ASEAN Harmonised Cosmetic Regulatory Scheme : ASEAN Guidelines for Cosmetic GMP
2016• GMP Inspection prior to Notification
GMP IMPLEMENTATION IN MALAYSIA
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2008 : ANNOUNCEMENT GMP REQUIREMENT UNDER NOTIFICATION SCHEME
GMP
REQUIREMENT
FOR
COSMETIC
Available at:
www.npra.moh.gov.my10
2016: GMP INSPECTION PRIOR TO NOTIFICATION
GMP requirement
before obtaining
Notification – for
New Cosmetic
Manufacturer
Only
Available at:
www.npra.moh.gov.my
Previous issue:
•Non-manufacturing
premise
•Non-compliance GMP
Status
•etc
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NO State No. Manufacturer
1. Johor 29
2. Kedah 21
3. Kelantan 7
4. Melaka 5
5. Negeri Sembilan 6
6. Pahang 0
7. Perak 13
8. Perlis 1
9. Pulau Pinang 28
10. Sabah 2
11. Sarawak 0
12. Selangor 101
13. Terengganu 0
14. W.P Kuala Lumpur 19
15. W.P Labuan 0
16. W.P Putrajaya 0
TOTAL : 232
COSMETIC MANUFACTURER ACCORDING TO STATES – FEB 2017
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GMP & GDP GUIDELINES
FOR MANUFACTURERS TO COMPLY
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GDP GMP
CURRENT INSPECTION GUIDELINE
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GOOD MANUFACTURING PRACTICE (GMP)
GMP ChaptersQuality Management
Personnel
Premises & Equipments
DocumentationProduction
Quality Control
Contract Manufacturing &
Analysis
Complaints & Product Recall
Self Inspection
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QUALITY MANAGEMENT
PERSONNEL
PREMISES AND FACILITIES
STOCK HANDLING AND STOCK CONTROL
DISPOSAL OF MATERIALS
DOCUMENTATION
VEHICLES AND EQUIPMENT
GOOD DISTRIBUTION PRACTICE (GDP)
TRANSPORTATION AND GOODS IN TRANSIT
COMPLAINTS
SELF INSPECTION
COUNTERFEIT
CONTRACT ACTIVITIES
LEGAL DOCUMENTS
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COMMON GMP FINDINGS &
PUNITIVE ACTION
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TOTAL GMP INSPECTION CARRIED OUT
Till Feb
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GMP DEFICIENCY ACCORDING TO CLASSIFICATION 2016 – 2017 (FEB)
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GMP FINDINGS IN % 2016 – 2017 (FEB)
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Premise & Equipment:
• Improper equipment, utility, premise maintenance – no
procedure, PPM, insufficient etc.
• Dirty production area
• Poor pest control
• Calibration issue
• Congestion, crowded inside production area
COMMON GMP ISSUE (1/2)
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• Procedures and Work Instructions not updated (i.e.
since 2005).
• Uses consultation service for GMP start-up but no
follow up on continuous GMP compliance.
• Final Quality Control testing not carried out prior to
market release.
• No specification set for the cosmetics (packaging, raw
material, quality control)
COMMON GMP ISSUE (2/2)
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EXAMPLES OF POOR GMP – YEAR 2014
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EXAMPLES OF POOR GMP – YEAR 2015
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EXAMPLES OF POOR GMP – YEAR 2015
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GMP EXAMPLES
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GMP EXAMPLES
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GMP EXAMPLES
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PUNITIVE ACTION
UNACCEPTABLE GMP COMPLIANCE!!!
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COSMETIC MANUFACTURER WITH ‘MINIMAL’ GMP COMPLIANCE
Till Feb
*Routine Inspection Only30
REGULATORY ACTION TAKEN AGAIN NON-GMP COMPLIANCE
Block & Cancellation
of NOT
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FinancialFamily Business: No awareness, interest
Attitude: No awareness, effort,
Knowledge: Financial, No
training, awareness
Teething
concerns
WHAT HAPPEN ?
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• GMP as a culture in the quality system
• Utilize GMP tools as CAPA and self-inspection
for improvement
• Self-learning and training
• GMP Inspection by NPRA ???
WAY TO MAKE PROGRESS
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GMP DIRECTIVES/CIRCULARS
RECENT DIRECTIVES/CIRCULARS
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GMP DIRECTIVES/CIRCULARS
Separation of
TMHS and
Cosmetic
Premise
Available at:
www.npra.moh.gov.my
2008
2011
2014
2016
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GMP DIRECTIVES/CIRCULARS (2)
Sharing facility
with ’insect
repellent’
product
Available at:
www.npra.moh.gov.my
2008
2011
2014
2016
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GMP DIRECTIVES/CIRCULARS (3)
New CAPA
Format2008
2011
2014
2016 Available at:
www.npra.moh.gov.my
Previous issue:
Poor CAPA reply
from manufacturer
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INITIATIVE TO ASSIST INDUSTRY
BY CENTRE FOR COMPLIANCE AND LICENSING
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GMP Workshop
June 2013
September 2013
September 2013 Hotel Grand Dorsett Subang, SubangJaya, Selangor
ISPE Training GMP
April 2016 Hotel Best Western, Petaling Jaya, Selangor
August 2016 Qliq Damansara, Damansara Perdana, Selangor
ISPE Training GDP
March 2016 Hotel Bangi-Putrajaya, Bandar BaruBangi, Selangor
PAST TRAINING EVENTS
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Initial Inspection within 10 working days when
received application for inspection via BPFK-
504
NEW COSMETIC MANUFACTURER
2016 Jan Feb Mac Apr May Jun Jul Aug Sept Oct Nov Dec Σ
Initial
Inspection0 1 3 0 5 3 5 2 4 6 0 3 32
2017 Jan Feb Mac Apr May Jun Jul Aug Sept Oct Nov Dec Σ
Initial
Inspection1 3 - - - - - - - - - - 4
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NPRA WEBPAGE – GMP MANUFACTURER LISTING
Monthly
update since
Jan 2016
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• Revision of ASEAN GMP Training
Modules
• Revision of MS HALAL for Notified
Cosmetic
• GMP Inspection for secondary
assembler
FUTURE…
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Terima
kasih
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