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An Update on Quality Control of Traditional Medicines

Ministry of Health Malaysia National Pharmaceutical Control Bureau. An Update on Quality Control of Traditional Medicines. Yogeswary Markandoo, Deputy Director, Centre for Quality Control. Ministry of Health Malaysia National Pharmaceutical Control Bureau. OBJECTIVE.

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An Update on Quality Control of Traditional Medicines

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  1. Ministry of Health Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines Yogeswary Markandoo, Deputy Director, Centre for Quality Control.

  2. Ministry of Health Malaysia National Pharmaceutical Control Bureau OBJECTIVE An Update on Quality Control of Traditional Medicines • Safety • Quality

  3. Ministry of Health Malaysia National Pharmaceutical Control Bureau Tests for Safety and Quality An Update on Quality Control of Traditional Medicines • Limit tests for Heavy Metals • Microbial limit tests • Disintegration test – tablets, capsules and pills • Uniformity of weight – tablets and capsules • Absence of scheduled medicines, banned alkaloids, synthetic chemicals.

  4. Ministry of Health Malaysia National Pharmaceutical Control Bureau Limit tests for Heavy Metals An Update on Quality Control of Traditional Medicines • Lead ≤ 10.0ppm • Arsenic ≤ 5.0ppm • Mercury ≤ 0.5ppm • Cadmium ≤ 0.3ppm (from 1 January 2005)

  5. Ministry ofHealth Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines

  6. Ministry of Health Malaysia National Pharmaceutical Control Bureau Microbial Limit Test An Update on Quality Control of Traditional Medicines • Total viable aerobic count : Bacteria and Fungus • Enterobacteria and certain other Gm negative bacteria • Free from Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella

  7. Ministry of Health Malaysia National Pharmaceutical Control Bureau Disintegration Test (for tablets, capsules and pills) An Update on Quality Control of Traditional Medicines • Uncoated Tablets • Film coated Tablets • Sugar coated Tablets • Enteric coated Tablets • Capsules • Pills

  8. Ministry of Health Malaysia National Pharmaceutical Control Bureau Uniformity of Weight(tablets and capsules only) An Update on Quality Control of Traditional Medicines • ≤ 2 tablets/ capsules > 10% of the average and none > 20% of the average weight

  9. Ministry of Health Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines

  10. Ministry of Health Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines • http://www.bpfk.gov.my

  11. Ministry of Health Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines Absence of :- • Adulterants - scheduled medicines (Poisons Act 1953) • Banned plants/alkaloids • Synthetic chemicals

  12. Ministry of Health Malaysia National Pharmaceutical Control Bureau Statistics (2003 and 2004)Traditional medicines An Update on Quality Control of Traditional Medicines

  13. Ministry of Health Malaysia National Pharmaceutical Control Bureau Future Tests An Update on Quality Control of Traditional Medicines • Limit test for pesticide residues • Limit test for residual solvents • Limit test for moisture content • Presence of aflatoxins

  14. Ministry of Health Malaysia National Pharmaceutical Control Bureau An Update on Quality Control of Traditional Medicines Terima Kasih Thank You

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