Batch Issuance, Purpose :
Batch Issuance, The purpose of this SOP (Standard Operating Procedure) is to provide a documented procedure for issuance of BMR and BPR.
Scope :
Batch Issuance, This procedure is applicable for issuance of BMR and BPR at XX Pharmaceuticals Limited (Both General and Sterile Block).
Definitions / Abbreviation:
[][]BMR: Batch Manufacturing Record
[][]BPR: Batch Packaging Record
[][]QCOM: Quality Assurance
Responsibilities:
[][]The roles and responsibility is as follows:
Executive, Quality Assurance
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Manager, Quality Assurance
[][]To ensure implementation of the SOP.
Manager, Quality Assurance
[][]Approval of the SOP.
Procedure:
[][]Issuance Procedure of Batch Manufacturing and Packaging Record (BMR/BPR).
[][]Fill up the respective BMR/BPR details in requisition form (Annexure-II) with signature of user and send to C for the issuance of respective BMR/BPR.
[][]On receipt of BMR/BPR requisition form from production department, QA shall enter the issuance entry in BMR/BPR issue register and then, photocopy the required copy of respective product BMR/BPR from the master copy of BMR/BPR.
[][]QA personnel shall enter the information related to Batch like Batch Number, Manufacturing Date, Expiry Date to photocopy of BMR/BPR.
[][]Send the photocopy of BMR/BPR to production department.
Annexure:
Annexure-I: Batch Issuance Register
Annexure-II: Batch Requisition Form