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, guidelines and policies and aligns closely with the QA policies of other UN agencies, key technical partners and international non-governmental agencies.
All products procured through GDF should meet the relevant quality assurance criteria described in the QA policy and must be approved for procurement and use by relevant national medicine regulatory authorities.
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GDF contracts independent third party internationally accredited or certified quality control and inspection Agents to carry out pre-shipment inspections, sampling and testing of medicines and diagnostics.
For further detailed information, please refer to GDF’s Quality Assurance Policy and GDF's Quality Monitoring Program.
QA Notifications:
- July 2024 - Urgent Field Safety Notice concerning BD BACTEC™ MGIT™ 960 PZA Kit manufactured by BD
- June 2024 - Urgent Field Safety Note concerning GXMTB/RIF-ULTRA-50 Kit B/N 1000714555- Lot 39116, manufactured by Cepheid
- March 2022 - Release of the quarantined batches and removal of the precautionary measures for Isoniazid 100mg tablet manufactured by Lupin, India
- February 2022 - Communication on Quarantine and Precautionary measures for Isoniazid 100mg tablet manufactured by Lupin, India
- December 2021 - Precautionary measures for GenoType MTBDRplus Ver 2.0 and MTBDRsl Ver 2.0
- 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
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