Information Notice

The Global Fund’s quality assurance information notices provide guidance and advice on how to operationalize in practical terms the consequences of a quality or a safety issue related to a product that has been procured with Global Fund funds. The initial information, stated in the notice, comes from the manufacturer of health products in question and/or is confirmed by stringent regulatory mechanisms.

Information Notices
- QA Information Notice 2023-06: Information on stability issue and reminder of the importance of manufacturer’s recommendation on environmental conditions during storage, transportation and distribution for Rifapentine 150mg tabs manufactured by Sanofi, Italy
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- QA Information Notice 2023-04: Risk mitigations measures for procuring of Insecticide Treated Net (ITN) product, SafeNet manufactured by Mainpol GmbH
  download in EnglishQA Information Notice 2023-04: Risk mitigations measures for procuring of Insecticide Treated Net (ITN) product, SafeNet manufactured by Mainpol GmbH
- QA Information Notice 2023-03: Precautionary measures for Uni-Gold HIV supplied by Trinity Biotech Manufacturing Ltd, Ireland
  download in EnglishQA Information Notice 2023-03: Precautionary measures for Uni-Gold HIV supplied by Trinity Biotech Manufacturing Ltd, Ireland
- QA Information Notice 2023-02: Updated Decision on the procurement of lubricants (sachets and tubes) manufactured by Cupid Limited, India and the request to quarantine Lubricants batches manufactured between January 2022 to date
  download in EnglishQA Information Notice 2023-02: Updated Decision on the procurement of lubricants (sachets and tubes) manufactured by Cupid Limited, India and the request to quarantine Lubricants batches manufactured between January 2022 to date
- QA Information Notice 2023-01_V2 : Reinstatement in the TGF QA eligibility list of TLD 300/300/50mg from Strides and manufactured by Universal Kenya and 3TC/ZDV 150/300 mg from Universal and manufactured by Universal Kenya.
  download in EnglishQA Information Notice 2023-01_V2 : Reinstatement in the TGF QA eligibility list of TLD 300/300/50mg from Strides and manufactured by Universal Kenya and 3TC/ZDV 150/300 mg from Universal and manufactured by Universal Kenya.
- QA Information Notice 2022-03: Temporary Suspension of procurement and delisting of pharmaceutical products which do not satisfy the criteria for authorization on Bioequivalence
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- QA Information Notice 2021-06: Precautionary Measures for GenoType MTBDRplus Ver 2.0 and MTBDRsl Ver 2.0 Supplied by Hain Lifescience GmbH, Germany
  download in EnglishQA Information Notice 2021-06: Precautionary Measures for GenoType MTBDRplus Ver 2.0 and MTBDRsl Ver 2.0 Supplied by Hain Lifescience GmbH, Germany
- QA Information Notice 2021-05: Precautionary measures for products supplied by Agio Pharmaceuticals Ltd., India.
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- QA Information Notice 2021-03: Precautionary measures in procuring IRS supplied by Bayer in water soluble bags
  download in EnglishQA Information Notice 2021-03: Precautionary measures in procuring IRS supplied by Bayer in water soluble bags
- QA Information Notice 2021-02: Suspension of procurement of Personal Protective Equipment supplied by Protectcare, Bangalore (India)
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- QA Information Notice 2021-01: Reinstatement of lubricating gel supplied by Karex Industries Sdn Bhd in the UNFPA catalogue for procurement
  download in EnglishQA Information Notice 2021-01: Reinstatement of lubricating gel supplied by Karex Industries Sdn Bhd in the UNFPA catalogue for procurement
- QA Information Notice 2020-07: To remind of the importance of manufacturer’s environmental conditions during storage, transportation and distribution for Clofazimine 100mg soft capsules manufactured by Sandoz Private Limited, Kalwe MIDC, Plot No.8-A/2, 8-B T.T.C, IND. AREA Village Dighe,Navi Mumbai, 400, India
  download in EnglishQA Information Notice 2020-07: To remind of the importance of manufacturer’s environmental conditions during storage, transportation and distribution for Clofazimine 100mg soft capsules manufactured by Sandoz Private Limited, Kalwe MIDC, Plot No.8-A/2, 8-B T.T.C, IND. AREA Village Dighe,Navi Mumbai, 400, India
- QA Information Notice 2020-04: Falsified rapid diagnostic tests to detect HIV-1/2 circulating in Guyana and Kenya
  download in EnglishQA Information Notice 2020-04: Falsified rapid diagnostic tests to detect HIV-1/2 circulating in Guyana and Kenya
- QA Information Notice 2020-02: Recall of Batches of Sofosbuvir 400mg tablets and Temporary suspension of procurement Sofosbuvir 400mg tablets, manufactured by European Egyptian Pharmaceutical Industry, Egypt
  download in EnglishQA Information Notice 2020-02: Recall of Batches of Sofosbuvir 400mg tablets and Temporary suspension of procurement Sofosbuvir 400mg tablets, manufactured by European Egyptian Pharmaceutical Industry, Egypt
- QA Information Notice 2020-01: Serious Quality Management System issues reported on the manufacturing site of Access Bio Inc located 65 Clyde Rd. Suite A, Somerset, NJ 08873 (USA)
  download in EnglishQA Information Notice 2020-01: Serious Quality Management System issues reported on the manufacturing site of Access Bio Inc located 65 Clyde Rd. Suite A, Somerset, NJ 08873 (USA)
- QA Information Notice 2019-09: Urgent Field Safety Notice for products manufactured by QIAGEN, QIAsymphony SP/AS - Operating the QIAsymphony SP with software version 5.0.3
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- QA Information Notice 2019-07: Recall of Batches of Co-Trimoxazole 120mg Dispersible tablets and Temporary suspension of procurement of Co-Trimoxazole 120mg Dispersible tablets, manufactured by Chi Pharmaceuticals Limited, Nigeria
  download in EnglishQA Information Notice 2019-07: Recall of Batches of Co-Trimoxazole 120mg Dispersible tablets and Temporary suspension of procurement of Co-Trimoxazole 120mg Dispersible tablets, manufactured by Chi Pharmaceuticals Limited, Nigeria
- QA Information Notice 2019-04: Suspension of manufacturing activities at Micro Labs Limited, Kumbalgodu, ML08, Bangalore (India)
  download in EnglishQA Information Notice 2019-04: Suspension of manufacturing activities at Micro Labs Limited, Kumbalgodu, ML08, Bangalore (India)
- QA Information Notice 2019-03: The Global Fund Position on the UK MHRA Statement of non-compliance with Good Manufacturing Practices (GMP) for Micro Labs Limited, Unit 3, Hosur (India)
  download in EnglishQA Information Notice 2019-03: The Global Fund Position on the UK MHRA Statement of non-compliance with Good Manufacturing Practices (GMP) for Micro Labs Limited, Unit 3, Hosur (India)
- QA Information Notice 2018-07: Reinstatement of Dongkuk Viet Nam Co., Ltd. to the WHO/UNFPA list of prequalified male latex condom manufacturer
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- QA Information Notice 2018-01: Briefing on the Recent Changes to the Global Fund Quality Assurance Policy for Diagnostic Products with Regards to the Procurement and Testing of Malaria Rapid Diagnostic Test (RDTs)
  download in EnglishQA Information Notice 2018-01: Briefing on the Recent Changes to the Global Fund Quality Assurance Policy for Diagnostic Products with Regards to the Procurement and Testing of Malaria Rapid Diagnostic Test (RDTs)