Brief presentation on the GPHF mini lab a method of testing used by the MQCL in the Department of Health,, Port Moresby, Papua New Guinea

1. GPHF Mini Lab
Presented by : Heni Oala (intern pharmacist)
01 October 2018

2. Outline
• Brief History
• Rationale
• Description Contents of Minilab
• Application
• Conclusion
• Acknowledgement
• References

3. Brief History
• Developed by Merck Germany, Global Pharma
Health Fund, 1996
• Richard W.O. Jähnke PhD in Pharmaceutical
formulations
• Targeting Low income countries Fight against
SSFFC medicines
• Over 500 minilabs supplied 80+ countries

4. Brief History
Figure1. GPHF Mini Lab founder
Source: gphf.org

5. Rationale
• Physical Test
1. Visual inspection: level 1
2. Disintegration tests: level 2
• Chemical Test: basic analytical tests
3. Thin Layer Chromatography: level 2
• Identify ; API content; impurities
• Semi-quantitative content evaluation, <5%,>20%,
5-20%, insensitive, highly specific

6. Three levels approach to QC of
Medicines
Level 3:
Compendial/validated
tests
Level 2: Basic
analytical
tests
Level 1:
Physical and
Visual
inspection
Source: Three level quality approach on the
quality of medicines, USPC. 2016

7. Contents: MiniLab
• 60-90 reference drug standards based on WHO
EM Model List
– 23 antimicrobials
– 12 antimalarials
– 13 anti-tb
– 3 antihelminthic
– 6 cardiovascular drugs
– 9 antiasthmatic, anti allergics, analgesics
– 6 others
• 9 optional items categories: ARV, antiTB, antiviral

8. Figure 2:Minilab kit showing contents
Contents: Mini Lab
• Glassware: sample extraction
• Chromatography Plates
• Developing, detection chambers
• Electronic balance
• UV lamp
• Hot plate
• Calliper rules
• SOP manuals

9. Contents: Mini Lab
• TLC equipment
• Protective case:
– 83 x 52 x 29 cm
– 25 kg
• Starter Kit chemicals
– 22-27 boxes
– 25kg

10. Technical details Mini Lab
• Storage: Compatible- tropics
– Avoid direct sunlight
• Shelf life:
– 2 years secondary reference standards
– 5 years for reagents and solvents (opened)
• Installation: out/indoors, well ventilated
areas >indoors, running water

11. Application of Mini Lab
• Detection of falsified and substandard
medicines
• Public drug procurements
• Consumer protection institutions
• Hospitals
• Scientific societies
• Medicines regulation authorities

12. Conclusion
• GPHF MiniLab
– Focus: essential medicines
– Medicines used in developing countries
– Priority diseases
– e.g. Diseases affecting Mother & Child
• Verify the quality of medicines accurately at a
low cost and protect patients consuming
substandard, counterfeit medicines

13. Source: http://www.gphf.org/en/minilab/manuals.html
Figure 3: Lab Manual for GPHF Minilabs

14. Acknowledgement
• Thankyou to all the Staff of the Medicines
Quality Control Lab of NDOH: especially Ms.
Georgina H and Mr. Ted

15. References
• https://www.gphf.org/en/minilab/index.htm
• https://www.researchgate.net/publication/289015309
/download
• GPHF Manual: Accompanying the GPHF-Minilab. Thin
Layer Chromatography tests. Supplement.2018
• Cummings, J. Taking Down a Goliath. The translational
scientist. 2018. Accessed:
https://theanalyticalscientist.com/issues/0118/taking-
doen-a-goliath/
• Three level quality approach on the quality of
medicines, USPC. 2016