190 likes | 604 Views
Kit Development Process. Kit Development Update. Kits provided by SCMS were not designed by SCMSKits, pharmaceuticals and supplementary supplies (Modules) have been selected and specified by consensus reached between many organisations:PEPFAR TWG (OGAC, USAID, CDC, NIH, DOD), WHO, UNAIDS, PSI, JHPIEGO, Gates Foundation, Clinton Foundation, FHI, MSI, ACHAP, EngenderHealth, C-Change, USAID HPI, JHUCCP, RHSP, OR, USCF.
E N D
1. Male Circumcision Procurement and Supply Chain Management:Progress Report Country Update Meeting, Arusha, Tanzania
June 8-10, 2010
Dr. Sameer Sakallah
Senior Technical Advisor, SCMS
2. Kit Development Process
3. Kit Development Update Kits provided by SCMS were not designed by SCMS
Kits, pharmaceuticals and supplementary supplies (Modules) have been selected and specified by consensus reached between many organisations:
PEPFAR TWG (OGAC, USAID, CDC, NIH, DOD), WHO, UNAIDS, PSI, JHPIEGO, Gates Foundation, Clinton Foundation, FHI, MSI, ACHAP, EngenderHealth, C-Change, USAID HPI, JHUCCP, RHSP, OR, USCF
4. Kit Development Update … cont. SCMS was asked to take the lead in MC kit development, procurement and supply chain management
Kit composition cannot be substituted or replaced:
SCMS did not design the kits
Any change will make the kit a new product
Standardization … better supply chain management … better pricing
5. Kit Development Update … cont. Re-usable Kit Option 1 for forceps guided procedure
Re-usable Kit Option 2 for sleeve resection and dorsal slit procedures
Disposable Kit Option 3 for forceps guided procedure
6. Kit Development Update … cont. Each kit contains all material needed to perform one MC operation
Pharmaceuticals (e.g. iodine, Paracetamol, Marcaine, etc.) cannot be included in these kits but are available in bulk separately
7. Additional Supplies Module 1. Infection Prevention & Waste Management
Module 2. Equipment
Module 3. Emergency Supplies
Kits, Pharmaceuticals and Modules and all their components are detailed in SCMS online catalog (eCatalog).
8. Kit Development Process: Disposable Kit Option 3 for forceps guided procedure STEP 1. Sourcing, Vendor Qualification, Price Quotation
Survey potential viable manufacturers
Vendor Qualifications: capability, financial stability, etc.
Price Quotation (based on an actual order)
9. Disposable Kit Option 3 …. Cont. STEP 2. Multi Vendor Selection
Request complete usable samples
Documentation
Commodity Manufacturing Source
Sample kit production: 2 complete, usable kit
10. Disposable Kit Option 3 …. Cont. STEP 3. Quality Check
Sterility Check
Component Quality
Site visits
11. Disposable Kit Option 3 …. Cont. STEP 4. Vendor(s) Selection & Price negotiation
Price is based on actual order
No procurement history
Customized product (cannot be returned)
Pooled orders a future possibility
12. Disposable Kit Option 3 …. Cont. STEP 5. Kit Manufacturing
Manufacturing Initial Lead Time is 3 months
Quality check: will perform sterility checks on each batch
Vendors under contract agree not to change suppliers without notice
13. Development of Kit Option 3: Results Initial vendors identified: 8
Vendors submitting bids: 5
Vendors submitting sample kits: 5
Vendors passing sterility test: 2
Final vendor count: 1
14. SCMS Delivers BEST VALUE Vendor physical and financial qualifications
Cannot always guarantee lowest price (although we try hard!!)
Specifications
Strict compliance with quality requirements
Manufacturing facility visits
Batch testing
15. Development of Kit Options 1 and 2(Re-usable Kits) Will have to go through the same process
Must have an actual order to negotiate price
Will work with countries to help pool orders
Availability estimated around the end of this year.
16. Country Updates Zimbabwe: 30,000 kits in manufacturing stage
Zambia: 10,000 kits ordered
Rwanda: first order of 5,000 kits being processed
Swaziland: order expected soon for first batch of 200,000 kits
Kenya: purchase of disposable kits currently under review
17. How can SCMS help? One stop shop
Procurement and delivery
Logistics
Supply Chain Management
Forecasting / Quantification
Warehousing and distribution
Technical assistance
Global collaboration for long-term, local and international solutions
18. USAID Contacts Mike Hope mhope@usaid.gov
Dr. Emmanuel Njeuhmeli enjeuhmeli@usaid.gov
Global Health Bureau
Office of HIV/AIDS
USAID
Washington, DC
19. SCMS Contacts Program Related Inquiries
David Jamieson, Deputy Director djamieson@pfscm.org
Dr. Sameer Sakallah, Senior Technical Advisor ssakallah@pfscm.org
Aliza Pressman, Program Officer apressman@pfscm.org
Procurement Inquiries
Elisha Kitula, Procurement Specialist ekitula@pfscm.org
SCMS
1616 Fort Myer Drive,12th Floor
Arlington, VA 22209, USA
Telephone 001-571-227-8600
20.
Thank You