Sourcing & Management of Health Products

The Global Fund / Karin Schermbrucker

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 2019-10: VOLUNTARY RECALL of Batch ECF7901A of Cycloserine 125 mg Capsules, supplied by Macleods and Suspension of procurement.
  download in 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
  download in 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 2019-07: 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 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”
  download in 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
  download in 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)
  download in 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)
  download in 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 2019-02: Temporary suspension of procurement of Artesunate / Amodiaquine tablets, manufactured by Guilin Pharmaceuticals
  download in English QA Information Notice 2019-02: Temporary suspension of procurement of Artesunate / Amodiaquine tablets, manufactured by Guilin Pharmaceuticals | Français psm_gfqainformationnotice2019-04-guilin_notice_fr.pdf
- 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 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 | 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
  download in 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
  download in English QA Information Notice 2018-06: Unlawfully displayed ACTm logo on boxes of Lesanto Laboratories
- QA Information Notice 2018-05-Falsified Combiart : Artemether 20 mg + Lumefantrine 120 mg tablets
  download in English QA Information Notice 2018-05-Falsified Combiart : Artemether 20 mg + Lumefantrine 120 mg tablets
- Quality Assurance Information Notice 2018-03 (update 1 October 2018): Eligibility Reinstated for Products Manufactured by Diagnostics for the Real World - SAMBA HIV-1 Semi-Q Test for use with SAMBA I Instrument and SAMBA II HIV-1 Semi-Q Test for use with SAMBA II Instrument
  download in English Quality Assurance Information Notice 2018-03 (update 1 October 2018): Eligibility Reinstated for Products Manufactured by Diagnostics for the Real World - SAMBA HIV-1 Semi-Q Test for use with SAMBA I Instrument and SAMBA II HIV-1 Semi-Q Test for use with SAMBA II Instrument
- Quality Assurance Information Notice 2018-04: REMEDICA Rapid Alert Notification CY/I/07/01: Falsified Quinine Sulphate tablets 300 mg
  download in English Quality Assurance Information Notice 2018-04: REMEDICA Rapid Alert Notification CY/I/07/01: Falsified Quinine Sulphate tablets 300 mg | Français psm_gfqainformationnotice2018-04_notice_fr.pdf
- Quality Assurance Information Notice 2018-03: Temporary Delisting of Products Manufactured by Diagnostics for the Real World - SAMBA HIV-1 Semi-Q Test for use with SAMBA I Instrument and SAMBA II HIV-1 Semi-Q Test for use with SAMABA II Instrument
  download in English Quality Assurance Information Notice 2018-03: Temporary Delisting of Products Manufactured by Diagnostics for the Real World - SAMBA HIV-1 Semi-Q Test for use with SAMBA I Instrument and SAMBA II HIV-1 Semi-Q Test for use with SAMABA II Instrument
- Quality Assurance Information Notice 2018-02: Dolutegravir (DTG) Use in Women of Childbearing Age – Safety Communication (8 June 2018)
  download in English Quality Assurance Information Notice 2018-02: Dolutegravir (DTG) Use in Women of Childbearing Age – Safety Communication (8 June 2018)
- 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 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)
- Quality Assurance Information Notice 2016-01: All Products Manufactured by Svizera Labs Private Limited, Turbhe, Navi, Mumbai, India - Eligibility Reinstated for Procurement with Global Fund Funds
  download in English Quality Assurance Information Notice 2016-01: All Products Manufactured by Svizera Labs Private Limited, Turbhe, Navi, Mumbai, India - Eligibility Reinstated for Procurement with Global Fund Funds
- Quality Assurance Information Notice 2017-01: Voluntary Recall Initiated by Lupin for Isoniazid Tablets BP 100mg, Batches No A301856, A302231, A302408
  download in English Quality Assurance Information Notice 2017-01: Voluntary Recall Initiated by Lupin for Isoniazid Tablets BP 100mg, Batches No A301856, A302231, A302408 | Español psm_gfqainformationnotice2017-01-lupin_notice_es.pdf | Français psm_gfqainformationnotice2017-01-lupin_notice_fr.pdf
- Quality Assurance Information Notice 2016-04: Remedica Product: Sulfadoxine / Pyrimethamine, 500/25 mg, Tablets - Eligibility Reinstated for Procurement with Global Fund Funds
  download in English Quality Assurance Information Notice 2016-04: Remedica Product: Sulfadoxine / Pyrimethamine, 500/25 mg, Tablets - Eligibility Reinstated for Procurement with Global Fund Funds
- Quality Assurance Information Notice 2016-03: Hetero Labs Product: Efavirenz, Lamivudine, and Tenofovir, 600/300/300 mg Tablets - No Longer Eligible for Procurement with Global Fund Funds
  download in English Quality Assurance Information Notice 2016-03: Hetero Labs Product: Efavirenz, Lamivudine, and Tenofovir, 600/300/300 mg Tablets - No Longer Eligible for Procurement with Global Fund Funds | Español psm_gfqainformationnotice2016-03-hetero_notice_es.pdf | Français psm_gfqainformationnotice2016-03-hetero_notice_fr.pdf
- Quality Assurance Information Notice 2016-01: Recommendations Following WHO PQP Suspension of all the Prequalified Products Manufactured by Svizera Labs Private Limited
  download in English Quality Assurance Information Notice 2016-01: Recommendations Following WHO PQP Suspension of all the Prequalified Products Manufactured by Svizera Labs Private Limited

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