Post on 04-Jan-2016
description
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Yogeswary Markandoo,
Deputy Director, Centre for Quality Control.
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
OBJECTIVE
SafetyQuality
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Tests for Safety and Quality
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.
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Limit tests for Heavy Metals
Lead ≤ 10.0ppm Arsenic ≤ 5.0ppm
Mercury ≤ 0.5ppm
Cadmium ≤ 0.3ppm (from 1 January 2005)
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An Update on Quality Control of Traditional Medicines
Ministry ofHealth Malaysia
National Pharmaceutical Control Bureau
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Microbial Limit Test
Total viable aerobic count : Bacteria and Fungus
Enterobacteria and certain other Gm negative bacteria
Free from Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Disintegration Test (for tablets, capsules and pills)
Uncoated Tablets
Film coated Tablets
Sugar coated Tablets
Enteric coated Tablets
Capsules
Pills
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Uniformity of Weight (tablets and capsules only)
≤ 2 tablets/ capsules > 10% of the average and none > 20% of the average weight
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
http://www.bpfk.gov.my
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Absence of :- Adulterants - scheduled
medicines (Poisons Act 1953)
Banned plants/alkaloids
Synthetic chemicals
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Statistics (2003 and 2004)Traditional medicines Year Number of
traditional samples
tested
Number of traditional samples failed
lab tests
% failed
2003 2615 298 11.4
2004 3404 429 12.6
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau
Future Tests
Limit test for pesticide residues
Limit test for residual solvents
Limit test for moisture content
Presence of aflatoxins
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An Update on Quality Control of Traditional Medicines
Ministry of Health Malaysia
National Pharmaceutical Control Bureau