National Institute of Biologics

Summary Protocol for Blood Grouping Reagents

	1. Specifications (in process) – Before Manufacturing Appearance pH Protein Content Optical Density at 630nm Reference used
	2. Performance (tested with approved standard lot calibrated against NIBSC standard or any other International reference standard) Immunological tests for Potency Immunological tests for Avidity i) Tests with EDTA test corpuscles ii)Tests with clotted test corpuscles Immunological tests for specificity
	3. Specifications (in process) – After Manufacturing Appearance Protein Content Sterility test Stability study Reference used
.	4. Specifications- Finished Product Appearance pH Protein Content Nacl content Optical Density at 630nm Reference used Volume
	5. Performance (tested with approved standard lot calibrated against NIBSC standard or any other International reference standard) Immunological tests for Potency Immunological tests for Avidity Tests with EDTA test corpuscles Tests with clotted test corpuscles Immunological tests for specificity
	6. Raw Material – Chemicals (BSA standard ) Description Solubility pH Optical Density at 540nm Moisture content Protein ALT contaminant AST contaminant LDH contaminant Reference used Storage condition
	7. Sodium Chloride - AR Molecular Formula Molecular Weight Description Solubility Identification Acidity or Alkalinity Clarity and Color of Solution Iron Loss on drying Assay Reference used Storage condition
	8. Sodium Azide - RG Molecular Formula Molecular Weight Description Solubility Water Insoluble matter Chloride Sulfate Assay Reference used Storage condition
	9 .Preservative-Thiomersal - RG Molecular Formula Molecular Weight Description Solubility Identification pH Loss on drying Assay Reference used Storage condition
	10. Specifications –Packing Material Teat butyl rubber Description Weight of one teat Total height Lip diameter Lip thickness Plunger diameter Chemical Test Fitting test with vial / cap/ dropper Color Reference used Glass vial Description Weight of one vial Total height Overflow capacity Body outer diameter Neck outer diameter Neck inner diameter Alkali Test Fitting and leakage test with rubber teat / cap/ dropper Color Reference used Glass dropper Description Weight Total height Rim diameter Top diameter Bottom diameter Wall thickness Drop Count Alkali Test Fitting test with cap/ vial/ rubber teat Color Reference used Cap with hole Description Total height Body outer diameter Inner diameter Hole diameter Wall thickness Fitting test with vial/ rubber teat/dropper Color Reference used Literature Description Grammage of paper Dimension Color Reference used Label Description Grammage Dimension Paper Color Background Text Cutting Printing matter Reference used Box printed Description Grammage of paper Dimension Color Reagent specific alphabet Text and Logo Reference used
	11. Specifications – Raw Material – Reagents a) Reagent Clone Concentrate Appearance Protein Content HBs Ag ELISA test HIV 1 + 2 ELISA test HCV ELISA test After dilution Appearance Protein Content pH Optical Density at 630nm Performance (tested with approved standard lot calibrated against NIBSC standard or any other International reference standard) i) Immunological tests for Potency ii) Immunological tests for Avidity Tests with EDTA test corpuscles Tests with clotted test corpuscles iii) Immunological tests for specificity Stability study Reference used Storage Condition
	b)Monoclonal diluent’s number 1 Appearance pH Performance -->Immunological tests for specificity Reference used Storage Condition
	c) Monoclonal diluent’s number 2 Appearance pH Performance -->Immunological tests for specificity Reference used Storage Condition
	d)Bovine Albumin – 10% Appearance pH Protein Content Performance -->Immunological tests for specificity Reference used Storage Condition
	e)Dye Solution Appearance Optical density at 630nm Performance -->Immunological tests for specificity Reference used Storage Condition
	12. Critical Raw Material and Clone Data Details and quality control i) Clone ii) Specificity iii) Intensity iv) Avidity v) Immunoglobulin Isotype vi) Potency (titre)

CHECK-LIST FOR BATCH PRODUCTION AND CONTROL RECORD

1. Product release certificate

i. Product Name
ii .Lot No.
iii.Mfg. date
iv Exp. Date
v.Quantity Manufactured
vi.Quantity Sampled
vii.Quantity Released

2.Test Requisition Slip – Checks as above at sl.no1
3.Batch Production Record

i.Product Name
ii. Lot Size
iii.Lot No.
iv.Mfg. date
v.Exp. Date
vi.Product description & label claim
vii.Date of commencement
viii.Date of completion
ix.Shelf-life
x.Storage conditions
xi.Details of manufacturing process & manufacturing unit

4.Certificate of Analysis
i.Appearance

ii.pH
iii.Protein content
iv.Potency
v.Avidity
vi.Specificity
vii.Tests for infectivity
viii.Sterility
ix.Stability

Documents to be scrutinized for batch release

1.Quality Control Protocol
2.Batch release Certificates
3.Name of three countries wherein the product is approved/marketed.
4.Copy of import license / manufacturing license
5.Pack insert

back to top || check list || specification- packing material || specification-raw materials reagent

Sample Tracking

Trainings and Workshops