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

3

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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