Malaysian Guidelines on Good Manufacturing Practice for Traditional Medicines and Health Supplements 1st Edition (2008)

  • General Information

The Guidelines on Good Manufacturing Practice (GMP) for the Traditional Medicines and Health Supplements (TMHS) which established in June 2008 on the ninth meeting of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) TMHS Product Working Group (PWG), is derived from the Malaysian Guidelines on GMP for Traditional Medicines (2003). The Guidelines were improved and revised further incorporating current requirements into a single set of guidelines to comply with stringent manufacturing and health requirements and follows the GMP for the production of TMHS products. These Guidelines are dynamic tools in ensuring that high quality products are produced in line with the current standards. It is being regularly updated, for instance, when the previous Guidelines on GMP for Traditional Medicines (2003) were revised, references were made to internationally recognized documents like EU - Annex 7; Manufacture of Herbal Medicinal Products (Volume 4; EU Guidelines to Good Manufacturing Practice), and WHO - Good Manufacturing Practices: Supplementary Guidelines for the Manufacture of Herbal Medicines and CRN - Council for Responsible Nutrition; Guidelines for Good Manufacturing Practice for Manufacturers of Food Supplements (1) (2).

The new GMP Guidelines for TMHS (2008) is acknowledged by the Pharmaceutical Inspection Corporation Scheme (PIC/S) as improved version in comparison to Annex 7 on herbal medicines of the PIC/S GMP Guide. The format and requirements of the new guidelines have been updated in which reference has been made to PIC/S Guide to GMP for Medicinal Products. The 14 Chapters of previous guide have been summarized into 9 chapters, namely Quality Management, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Contract Production and Testing, Distribution, Complaints and Product Recalls and Self Inspection (1) (2).

There are new requirements related to traditional medicines made in the Guidelines on GMP for TMHS (2008) including in Chapter 3 for Premises and Equipment (para 3.6) mentioned about manufacturing of traditional medicines and health supplements should be done in separate facilities unless the cross-contamination issue can be adequately addressed sharing of manufacturing facilities may be considered. Another requirement in Chapter 5 for Production (para 5.16) stated that the production of products other than traditional medicines and health supplements should be avoided in the same production areas (1) (2).

 

  • Contact Details

National Pharmaceutical Control Bureau (NPCB)
Biro Pengawalan Farmaseutikal Kebangsaan
Lot 36, Jalan Universiti
46200 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +603-7883 5400
Fax: +603-7956 2924, +603-7956 7075
Website: http://www.bpfk.gov.my

References:

  1. National Pharmaceutical Control Bureau. Guidelines on good manufacturing practice for traditional medicines and health supplements. 1st ed. National Pharmaceutical Control Bureau. Kuala Lumpur; 2008.
  2. National Pharmaceutical Control Bureau. Implementation of the new GMP guidelines for TMHS. Malaysia: Centre for Compliance and Licensing, NPCB; 2008[cited 2012 Oct 30]. Available from: http://portal.bpfk.gov.my/index.cfm?&menuid=122