Supply of Medicine and Medical / Surgical equipments : Anti-IgG+C3D(poli)AntiHu.Glob.10ml\nSpecification :\nAnti Human Globulin(Coombs)green- Polyspecific Anti\nIgG + C3D 10ml\n1. The method of manufacture should result in a\nproduct within an immediate container that is\nhomogeneous and free of properties which adversely\naffect its intended use throughout its recommended\nshelf life. The reagent should have no precipitate,\nparticles or fibrin gel.\n2. Each batch or sub-batch should be specifically\nidentified by a Distinctive combination of numbers\nand/or letters (batch reference) which permits its\nhistory to be traced.\n3. Reagents should be produced by a validated process\nthat is shown to be suitable for the intended\npurpose.\n4. Volume should be mentioned in milliliters (ml) on\nimmediate container\n5. Absence of rouleaux formation, prozone and\nhaemolysis.\n6. Labelling requirements;\nA. Should have a label on the immediate container\nB. Printing on all final container labels shall be in solid\nblack.\nC. The label fixed to the immediate container of a\nreagent should leave uncovered sufficient area of\nthe full length or circumference of the container to\nallow ready visual inspection of the contents.\nD. The specificity of the reagent for blood group\nserology should be of a Print size which is clearly\nlegible. The print size of other information on the\nlabel should not exceed that used for the specificity\nof the reagent.\nE. Should include Lot number and sub lot designations,\nif available\nF. Expiry date should be mentioned.\nG. Should mention the recommended storage\ntemperature (2-6 ?C)\n7. Precautions must be taken to maintain the cold chain\nwhile transportation until it reaches the blood bank, as\nthese reagents are kept at 2-6 ?C.\n8. Reagent shall contain FDA and/or WHO certification/\ncountry of origin certificate and certificate of use in\nthe country of origin/end user evaluation certificate/free\nsales certificate in USA,UK, France, Germ

STATE PHARMACEUTICALS CORPORATION OF SRI LANKA Sri Lanka has Released a tender for Supply of Medicine and Medical / Surgical equipments : Anti-IgG+C3D(poli)AntiHu.Glob.10ml\nSpecification :\nAnti Human Globulin(Coombs)green- Polyspecific Anti\nIgG + C3D 10ml\n1. The method of manufacture should result in a\nproduct within an immediate container that is\nhomogeneous and free of properties which adversely\naffect its intended use throughout its recommended\nshelf life. The reagent should have no precipitate,\nparticles or fibrin gel.\n2. Each batch or sub-batch should be specifically\nidentified by a Distinctive combination of numbers\nand/or letters (batch reference) which permits its\nhistory to be traced.\n3. Reagents should be produced by a validated process\nthat is shown to be suitable for the intended\npurpose.\n4. Volume should be mentioned in milliliters (ml) on\nimmediate container\n5. Absence of rouleaux formation, prozone and\nhaemolysis.\n6. Labelling requirements;\nA. Should have a label on the immediate container\nB. Printing on all final container labels shall be in solid\nblack.\nC. The label fixed to the immediate container of a\nreagent should leave uncovered sufficient area of\nthe full length or circumference of the container to\nallow ready visual inspection of the contents.\nD. The specificity of the reagent for blood group\nserology should be of a Print size which is clearly\nlegible. The print size of other information on the\nlabel should not exceed that used for the specificity\nof the reagent.\nE. Should include Lot number and sub lot designations,\nif available\nF. Expiry date should be mentioned.\nG. Should mention the recommended storage\ntemperature (2-6 ?C)\n7. Precautions must be taken to maintain the cold chain\nwhile transportation until it reaches the blood bank, as\nthese reagents are kept at 2-6 ?C.\n8. Reagent shall contain FDA and/or WHO certification/\ncountry of origin certificate and certificate of use in\nthe country of origin/end user evaluation certificate/free\nsales certificate in USA,UK, France, Germ in Pharmaceuticals. The tender was released on Jan 08, 2025.

Country - Sri Lanka

Summary - Supply of Medicine and Medical / Surgical equipments : Anti-IgG+C3D(poli)AntiHu.Glob.10ml\nSpecification :\nAnti Human Globulin(Coombs)green- Polyspecific Anti\nIgG + C3D 10ml\n1. The method of manufacture should result in a\nproduct within an immediate container that is\nhomogeneous and free of properties which adversely\naffect its intended use throughout its recommended\nshelf life. The reagent should have no precipitate,\nparticles or fibrin gel.\n2. Each batch or sub-batch should be specifically\nidentified by a Distinctive combination of numbers\nand/or letters (batch reference) which permits its\nhistory to be traced.\n3. Reagents should be produced by a validated process\nthat is shown to be suitable for the intended\npurpose.\n4. Volume should be mentioned in milliliters (ml) on\nimmediate container\n5. Absence of rouleaux formation, prozone and\nhaemolysis.\n6. Labelling requirements;\nA. Should have a label on the immediate container\nB. Printing on all final container labels shall be in solid\nblack.\nC. The label fixed to the immediate container of a\nreagent should leave uncovered sufficient area of\nthe full length or circumference of the container to\nallow ready visual inspection of the contents.\nD. The specificity of the reagent for blood group\nserology should be of a Print size which is clearly\nlegible. The print size of other information on the\nlabel should not exceed that used for the specificity\nof the reagent.\nE. Should include Lot number and sub lot designations,\nif available\nF. Expiry date should be mentioned.\nG. Should mention the recommended storage\ntemperature (2-6 ?C)\n7. Precautions must be taken to maintain the cold chain\nwhile transportation until it reaches the blood bank, as\nthese reagents are kept at 2-6 ?C.\n8. Reagent shall contain FDA and/or WHO certification/\ncountry of origin certificate and certificate of use in\nthe country of origin/end user evaluation certificate/free\nsales certificate in USA,UK, France, Germ

Deadline - Jan 27, 2025

GT reference number - 101101687

Product classification - Pharmaceutical products