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Calibration of the human immunoglobulin BRPs for ACA and molecular size (batch 1) and for Fc function and molecular size (batches 1 & 2)
molecular size determination by HPLC. All 3 BRP s are to be used in conjunction with the monographs Human normal immunoglobulin (0338) and Human normal immunoglobulin for intravenous administration (0918). ...
Guidelines for Independent Lot Release of Vaccines by Regulatory Authorities
recommendations and strategies for lot release of vaccines by the NRA s/ NCL s of producing and procuring countries. It should be read in conjunction with the recommendations/guidelines for specific products (e.g., ...