![]() ![]() IPQA personnel shall ensure that the control samples and other samples like stability /microbiology/ validation samples in a product have been collected as applicable.Production shall submit Batch Manufacturing Record and Batch Packaging Record after review and approval by Production Officer/ Executive and final review of Head, Production to QA for onward review by Quality Assurance.Conditional transfer: The transfer of finished product from the manufacturing location to Macleod’s Finished Goods Warehouse or Carrying and Forwarding Agents (C&F) prior release of the batch but not for sale and distribution.Responsible for Approval of batch for conditional transfer. Head – QA: Responsible for approval and release of the batch.Plant Head: Approval of requisition in case of conditional transfer of product.QA (QC Compliance): For the review of Analytical / Microbiology Data (Hard copy / Soft Copy) along with COA.H ead, QC / QM: For completion and review of analytical / microbiology records for adequacy.Head-Production: For completion and review of BMR/ BPR for adequacy.Officer / Executive, QA / Production: responsible for reviewing the batch record for its completeness and accuracy.This Standard Operating Procedure is applicable for all batches of finished products manufactured at the pharmaceutical drug manufacturing plant.ģ.0 RESPONSIBILITY – SOP FOR BATCH RELEASE:.To lay down the procedure for approval and release of the finished product batch. ![]() ![]() Procedure for Finished Product Batch Release 1.0 PURPOSE: Standard Operating Procedure (SOP) for approval and release of Finished Product Batch for moving from the manufacturing site to supply chain/distributors or C&F warehouses. ![]()
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