GDF has a rigorous quality assurance policy in place to guarantee the safety, efficacy, and quality of the products it provides. This comprehensive policy is guided by WHO standards and policies and aligns closely with the policies of other UN agencies, key technical partners and international non-governmental agencies.
Products procured through GDF should meet quality assurance criteria, and must be either prequalified by WHO, or authorized for use by a Stringent Regulatory Authority (SRA) as defined and listed by WHO or be recommended for short-term procurement by the Expert Review Panel (ERP).
All products must be approved for procurement and use by relevant national medicine regulatory authorities. In vitro diagnostic and medical devices must comply with the quality standards and referential norms set by the WHO Global Laboratory Initiative, WHO Prequalification of In Vitro Diagnostics Programme; WHO Department of Essential Health Technologies and WHO consolidated guidelines on Tuberculosis.
GDF contracts external internationally accredited or certified quality control and inspection Agents to carry out independent pre-shipment inspections, sampling and testing of medicines and diagnostics.
- October 2021 - WHO PQT on Nitrosamine concerns in rifampicin products - Update
- November 2020 - TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product
- October 2020 - Information Notice regarding the importance of storage conditions for Clofazimine 100mg in capsules at all levels
- September 2020 - TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product
- July 2020 - Nitrosamine concerns in Priftin (Rifapentine)
- June 2020 - Voluntary recall of Isoniazid 100mg tablets from Lupin
- October 2019 - Voluntary recall of Cycloserine 125mg capsules from Macleods
- September 2019 - Field Notice for SUB-D reagent contained in several kits manufactured by Hain
- June 2019 - TGF Position on the UK MHRA Statement of non-compliance with Good Manufacturing Practices (GMP), Micro Labs, Unit ML 03 , Hosur
- May 2019 - Voluntary Recall Initiated by Macleods for Moxifloxacin 100mg DT BN BMC5801A
- April 2019 - Suspension of manufacturing activities at Micro Labs Limited