GMP Cosmetic in Malaysia: The Past & Present

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1 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

2 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 2

3 FROM REGISTRATION TO SELF REGULATION Law & Regulations : Control of Cosmetics in Malaysia 3

4 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; 4

5 CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984 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 5

6 UNNOTIFIED COSMETIC Offence under: Regulation1 8A, Control of Drug and Cosmetic Regulation General Penalty: Section 12(1) Sales of Drug Act (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. 6

7 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) 7

8 CONTROL OF COSMETICS IN MALAYSIA 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. 8

9 GMP IMPLEMENTATION IN MALAYSIA First draft based on pharmaceutical guideline Joint drafting committee- NPCB and representatives from cosmetic industry. Malaysian GMP Cosmetic Guideline ASEAN Harmonised Cosmetic Regulatory Scheme : ASEAN Guidelines for Cosmetic GMP GMP Inspection prior to Notification 9

10 2008 : ANNOUNCEMENT GMP REQUIREMENT UNDER NOTIFICATION SCHEME GMP REQUIREMENT FOR COSMETIC Available at: 10

11 2016: GMP INSPECTION PRIOR TO NOTIFICATION Previous issue: Non-manufacturing premise Non-compliance GMP Status etc GMP requirement before obtaining Notification for New Cosmetic Manufacturer Only Available at: 11

12 COSMETIC MANUFACTURER ACCORDING TO STATES FEB 2017 NO State No. Manufacturer 1. Johor Kedah Kelantan 7 4. Melaka 5 5. Negeri Sembilan 6 6. Pahang 0 7. Perak Perlis 1 9. Pulau Pinang Sabah Sarawak Selangor Terengganu W.P Kuala Lumpur W.P Labuan W.P Putrajaya 0 TOTAL :

13 FOR MANUFACTURERS TO COMPLY GMP & GDP GUIDELINES 13

14 CURRENT INSPECTION GUIDELINE GDP GMP 14

15 GOOD MANUFACTURING PRACTICE (GMP) Documentation Production Quality Control Premises & Equipments Contract Manufacturing & Analysis Personnel Complaints & Product Recall Quality Management GMP Chapters Self Inspection 15

16 GOOD DISTRIBUTION PRACTICE (GDP) QUALITY MANAGEMENT PERSONNEL PREMISES AND FACILITIES STOCK HANDLING AND STOCK CONTROL DISPOSAL OF MATERIALS DOCUMENTATION VEHICLES AND EQUIPMENT TRANSPORTATION AND GOODS IN TRANSIT COMPLAINTS SELF INSPECTION COUNTERFEIT CONTRACT ACTIVITIES LEGAL DOCUMENTS 16

17 COMMON GMP FINDINGS & PUNITIVE ACTION 17

18 TOTAL GMP INSPECTION CARRIED OUT Till Feb 18

19 GMP DEFICIENCY ACCORDING TO CLASSIFICATION (FEB) 19

20 GMP FINDINGS IN % (FEB) 20

21 COMMON GMP ISSUE (1/2) 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 21

22 COMMON GMP ISSUE (2/2) 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) 22

23 EXAMPLES OF POOR GMP YEAR

24 EXAMPLES OF POOR GMP YEAR

25 EXAMPLES OF POOR GMP YEAR

26 GMP EXAMPLES 26

27 GMP EXAMPLES 27

28 GMP EXAMPLES 28

29 PUNITIVE ACTION UNACCEPTABLE GMP COMPLIANCE!!! 29

30 COSMETIC MANUFACTURER WITH MINIMAL GMP COMPLIANCE Till Feb *Routine Inspection Only 30

31 REGULATORY ACTION TAKEN AGAIN NON-GMP COMPLIANCE Block & Cancellation of NOT 31

32 WHAT HAPPEN? Financial Family Business: No awareness, interest Attitude: No awareness, effort, Teething concerns Knowledge: Financial, No training, awareness 32

33 WAY TO MAKE PROGRESS 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??? 33

34 RECENT DIRECTIVES/CIRCULARS GMP DIRECTIVES/CIRCULARS 34

35 GMP DIRECTIVES/CIRCULARS Separation of TMHS and Cosmetic Premise 2016 Available at: 35

36 GMP DIRECTIVES/CIRCULARS (2) Sharing facility with insect repellent product 2016 Available at: 36

GMP DIRECTIVES/CIRCULARS (3) 2008 New CAPA Format 2011 2014 Previous issue:

37 GMP DIRECTIVES/CIRCULARS (3) 2008 New CAPA Format Previous issue: Poor CAPA reply from manufacturer 2016 Available at: 37

38 BY CENTRE FOR COMPLIANCE AND LICENSING INITIATIVE TO ASSIST INDUSTRY 38

39 PAST TRAINING EVENTS GMP Workshop ISPE Training GMP ISPE Training GDP June 2013 September 2013 September 2013 April 2016 August 2016 March 2016 Hotel Grand Dorsett Subang, Subang Jaya, Selangor Hotel Best Western, Petaling Jaya, Selangor Qliq Damansara, Damansara Perdana, Selangor Hotel Bangi-Putrajaya, Bandar Baru Bangi, Selangor 39

40 NEW COSMETIC MANUFACTURER Initial Inspection within 10 working days when received application for inspection via BPFK Jan Feb Mac Apr May Jun Jul Aug Sept Oct Nov Dec Σ Initial Inspection Jan Feb Mac Apr May Jun Jul Aug Sept Oct Nov Dec Σ Initial Inspection

41 NPRA WEBPAGE GMP MANUFACTURER LISTING Monthly update since Jan

42 FUTURE Revision of ASEAN GMP Training Modules Revision of MS HALAL for Notified Cosmetic GMP Inspection for secondary assembler 42

43 Terima kasih 43 43

ROLE OF MSMA IN PROMOTING SUSTAINABLE URBAN DRAINAGE SYSTEM IN MALAYSIA. Urban Drainage Division Department of Irrigation and Drainage Malaysia

ROLE OF MSMA IN PROMOTING SUSTAINABLE URBAN DRAINAGE SYSTEM IN MALAYSIA Urban Drainage Division Department of Irrigation and Drainage Malaysia INTRODUCTION BACKGROUND WATER QUANTITY CONTROL WATER QUALITY