policy on quality assurance for single and limited-source pharmaceuticals
DESCRIPTION
Policy on Quality Assurance for Single and Limited-Source Pharmaceuticals. Nairobi, Kenya, 20 – 24 February 2006. Background. The procurement policy of the GF specifies certain conditions under which the grant recipients can procure single or limited source pharmaceutical products *). - PowerPoint PPT PresentationTRANSCRIPT
Policy on Quality Assurance for Single and Limited-Source Pharmaceuticals
Nairobi, Kenya, 20 – 24 February 2006
Background
The procurement policy of the GF specifies certain conditions under which the grant recipients can procure single or limited source pharmaceutical products *).
Option A: Products pre-qualified by WHO (UN procurement quality and sourcing project)
Option B: Products authorized for consumption by a stringent regulatory authority **)
Option C: Products authorized by the NDRA of the Recipient country.
Concern was raised that many recipient countries National Drug Regulatory Authorities (NDRA) may not have the technical capacity and resources to carry out the necessary quality assurance.
*) Pharmaceutical products for which there are not publicly available quality assurance standards, analytical methods and reference standards
**) An authority either belonging to the International Conference on Harmonization of Technical requirements of registration of pharmaceuticals for human use (ICH) or to the pharmaceutical Inspection Cooperation Scheme (PIC/S).
Decision to change the Policy
During the 10th Board meeting in April 2005 the Board approved new and amended guidelines for the Policy on Quality Assurance for
Single and Limited-Source Pharmaceuticals.
Policy changes
Old Policy New Policy
Option A: Products pre-qualified by WHO (UN procurement quality and sourcing project)
Option A: The same
Option B: Products authorized for consumption by a stringent regulatory authority
Option B: The same
Option C: Products authorized by the NDRA of the Recipient country.
Option Ci: The manufacturer has submitted an application for pre-qualification to the WHO or approval from a stringent regulatory authority and the manufacturing site is GMP compliant as certified by WHO or a stringent regulatory authority.
Option Cii: The product is manufactured at a GMP compliant manufacturing site as certified by WHO or a stringent regulatory authority
Application
2 manufacturers of equivalent products
2 manufacturers of equivalent products
Number of Option (a) or (b) manufacturers
producing equivalent products
Has to procure from one of the (a) or (b)
suppliers
* Product defined as: chemical + strength + formulation
If products unavailable, PR informs Secretariat and then:
** Unavailability defined as: inability of the manufacturer to supply a sufficient quantity of finished product within 90 days from date of order.
(i) The manufacturer has submitted an application to the
WHO or a stringent regulatory authority
and the manufacturing site is
GMP compliant.
IF NOT, THEN
(ii) Manufactured in a GMP-compliant
manufacturing facilityThe PR is required to notify GF if procuring under (i) or (ii)
2 manufacturers of equivalent
products
Has to procure from one of the
(a) or (b) suppliers
2 manufacturers of equivalent
productsNumber of
Option (a) or (b) manufacturers
producing equivalent products
If products
unavailable, PR
informs Secretaria
t and then: Principal Recipients:
Shall promptly notify the global fund in writing if it plans to procure any products pursuant option Ci or Cii
Shall obtain documentation of the application and/or GMP compliance
Shall permit access to storage sites and removal of samples
Obligations
(i) The manufacturer has
submitted an application to the
WHO or a stringent
regulatory authority and the
manufacturing site is GMP compliant.
IF NOT, THEN
(ii) Manufactured in a GMP-compliant
manufacturing facility
TGF Secretariat:
TGF shall contract an independent 3rd party to conduct random quality analysis of products procured pursuant option Ci or Cii
Conditions
1 Contracts entered before April 30, 2005 may be honoured until they expire or otherwise terminate.
2After April 30, 2005, the Principal Recipient may not enter into any new contracts, nor extend any existing contracts, for the supply of products that would have qualified for purchase under the original Clause 3.
3If there are less than 2 suppliers according to Option (A) or (B), or if products from these suppliers are unavailable then Grant funds may be used to procure products according to Option Ci or Cii (In order of priority)
4PR shall revert to Option (A) or (B) as soon as products from 2 or more suppliers become available.
Key actions taken
Development of a list of products found compliant with The Global Fund Policy on Quality Assurance.
Short term implementation of interim quality control testing by an independent 3rd party.
Initiated the development of a permanent solution to more comprehensive Quality Control Testing
The Global Fund Compliance List
Key features of the compliance list:
Split by disease area (HIV – TB – Malaria)
Ordered according to the ingredient / generic name of the product
Information:•Product•Strength•Dosage form•GF classification (A, B, Ci or Cii)•Name of supplier•Approval authority (WHO or Regulatory authority)•Address of manufacturing site•Packaging type•Packaging size
A
B
C
The Global Fund Compliance List
The Global Fund
Home page
Procurement and Supply
Management
Quality Assurance Information
Compliance List –
Front page
Actual Compliance
ListsHIVTB
Malaria
The Global Fund Compliance List
Follow this link:
http://www.theglobalfund.org/en/about/procurement/quality/