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 Notices29
- The QA information notice 2022-01 has been withdrawn. All additional QC testing results comply with standards and therefore the potential quality issue has not been confirmed for the Artesunate powder for injection 60mg manufactured and commercialized by IPCA
- 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 2021-03: 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 2021-05: Precautionary measures for products supplied by Agio Pharmaceuticals Ltd., India.
  download in EnglishQA Information Notice 2021-05: Precautionary measures for products supplied by Agio Pharmaceuticals Ltd., India.
- QA Information Notice 2021-02: Suspension of procurement of Personal Protective Equipment supplied by Protectcare, Bangalore (India)
  download in EnglishQA Information Notice 2021-02: Suspension of procurement of Personal Protective Equipment supplied by Protectcare, Bangalore (India)
- 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 2020-08 Version 2: TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product.
  download in EnglishQA Information Notice 2020-08 Version 2: TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product.
- QA Information Notice 2020-08: TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product.
  download in EnglishQA Information Notice 2020-08: TGF Position on the US FDA approach to mitigate shortages of rifapentine after manufacturer found nitrosamine impurities in his product.
- 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 2020-06: Voluntary recall of 8 Batches of Isoniazid Tablets BP 100mg, supplied by Lupin Ltd India
  download in EnglishQA Information Notice 2020-06: Voluntary recall of 8 Batches of Isoniazid Tablets BP 100mg, supplied by Lupin Ltd India
- QA Information Notice 2020-05: Voluntary recall of 20 Batches of Isoniazid Tablets BP 100mg, supplied by Lupin Ltd India.
  download in EnglishQA Information Notice 2020-05: Voluntary recall of 20 Batches of Isoniazid Tablets BP 100mg, supplied by Lupin Ltd 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 2020-03: Temporary suspension of procurement of Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride)dispersible tablets, manufactured by SKANT LTD, India
  download in EnglishQA Information Notice 2020-03: Temporary suspension of procurement of Pyrimethamine/Sulfadoxine + Amodiaquine (hydrochloride)dispersible tablets, manufactured by SKANT LTD, India
- 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 2019-02b: Artesunate / Amodiaquine tablets, manufactured by Guilin Pharmaceuticals Eligibility reinstated for procurement with Global Fund (GF) funds
  download in EnglishQA Information Notice 2019-02b: Artesunate / Amodiaquine tablets, manufactured by Guilin Pharmaceuticals Eligibility reinstated for procurement with Global Fund (GF) funds
- QA Information Notice 2019-11: Re-instatement of the WHO Prequalification status of Tsara Soft commercialized by NRS Moon Netting
  download in EnglishQA Information Notice 2019-11: Re-instatement of the WHO Prequalification status of Tsara Soft commercialized by NRS Moon Netting
- QA Information Notice 2019-10: VOLUNTARY RECALL of Batch ECF7901A of Cycloserine 125 mg Capsules, supplied by Macleods and Suspension of procurement.
  download in EnglishQA Information Notice 2019-10: VOLUNTARY RECALL of Batch ECF7901A of Cycloserine 125 mg Capsules, supplied by Macleods and Suspension of procurement.
- 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
  download in EnglishQA 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
- QA Information Notice 2019-08: Precautionary measures with Interceptor G2 Nets commercialized by BASF
  download in EnglishQA Information Notice 2019-08: Precautionary measures with Interceptor G2 Nets commercialized by BASF
- 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 2019-06: Voluntary recall initiated by Macleods for ”Moxifloxacin Dispersible tablets 100mg - Batch No BMC5801A”
  download in EnglishQA Information Notice 2019-06: Voluntary recall initiated by Macleods for ”Moxifloxacin Dispersible tablets 100mg - Batch No BMC5801A”
- QA Information Notice 2019-05: Unlawfully displayed ACTm logo on boxes of Artemether + Lumefantrine 20mg + 120mg bearing various manufacturer names found in Nigeria
  download in EnglishQA Information Notice 2019-05: Unlawfully displayed ACTm logo on boxes of Artemether + Lumefantrine 20mg + 120mg bearing various manufacturer names found in 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 2019-01: Quality issues with DawaPlus 2.0 commercialized by Tana Nettings Co Ltd manufactured by H. Sheikh Noorud - Din & Sons (HSNDS) - Revised version
  download in EnglishQA Information Notice 2019-01: Quality issues with DawaPlus 2.0 commercialized by Tana Nettings Co Ltd manufactured by H. Sheikh Noorud - Din & Sons (HSNDS) - Revised version Françaispsm_gfqainformationnotice2019-01-tananettings_notice_fr.pdf
- QA Information Notice 2018-07: Suspension of Dongkuk Viet Nam Co., Ltd. from the WHO/UNFPA list of prequalified male latex condom manufacturer
  download in EnglishQA Information Notice 2018-07: Suspension of Dongkuk Viet Nam Co., Ltd. from the WHO/UNFPA list of prequalified male latex condom manufacturer
- QA Information Notice 2018-06: Unlawfully displayed ACTm logo on boxes of Lesanto Laboratories
  download in EnglishQA Information Notice 2018-06: Unlawfully displayed ACTm logo on boxes of Lesanto Laboratories
- Quality Assurance 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 EnglishQuality Assurance 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)