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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.
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.
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English 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.
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.
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English 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.
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
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English 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
QA Information Notice 2020-06: Voluntary recall of 8 Batches of Isoniazid Tablets BP 100mg, supplied by Lupin Ltd India
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English QA 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.
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English QA 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
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English QA 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
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English QA 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
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English 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
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)
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English 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)
QA Information Notice 2019-02b: Artesunate / Amodiaquine tablets, manufactured by Guilin Pharmaceuticals Eligibility reinstated for procurement with Global Fund (GF) funds
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English QA 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
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English QA 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.
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English QA 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
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English 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
QA Information Notice 2019-08: Precautionary measures with Interceptor G2 Nets commercialized by BASF
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English QA 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
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English 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
QA Information Notice 2019-06: Voluntary recall initiated by Macleods for ”Moxifloxacin Dispersible tablets 100mg - Batch No BMC5801A”
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English QA 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
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English QA 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)
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English QA 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)
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English 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)
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
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English 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
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Français psm_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
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English QA 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
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English QA Information Notice 2018-06: Unlawfully displayed ACTm logo on boxes of Lesanto Laboratories
Quality Assurance Information Notice 2018-04: REMEDICA Rapid Alert Notification CY/I/07/01: Falsified Quinine Sulphate tablets 300 mg
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English Quality Assurance Information Notice 2018-04: REMEDICA Rapid Alert Notification CY/I/07/01: Falsified Quinine Sulphate tablets 300 mg
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Français psm_gfqainformationnotice2018-04_notice_fr.pdf
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)
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English 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)
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