To lay down the procedure for Issue, Receipt, Review, Movement, Cancellation, Storage and Destruction of Batch Production and Control Records.
1. PURPOSE
To lay down the procedure for Issue, Receipt, Review, Movement, Cancellation, Storage and Destruction of Batch Production and Control Records.
2.0 SCOPE
2.1 This procedure is applicable for various Batch Production and Control Records (BPCR) in Quality Assurance and Production departments.
3.0 RESPONSIBILITY
3.1 Assistant / Executive -Quality Assurance
3.2 Manger-Production
4.0 ACCOUNTABILITY
4.1 Manager – Quality Assurance
5.0 PROCEDURE
5.1 Issue of BPCR
5.1.1 Production Department shall request their requirement to Quality Assurance as per BPCR issue request (Annexure – I).
5.1.2 QA shall photocopy the required number of BPCRs and respective Raw Material Issuance Record (two sets) from the Documentation cell copy.
5.1.3 All particulars shall be entered in the “BPCR Issue and Receipt Record” as per the format given in Annexure – I. The batch number shall be allotted as per Assigning Batch Number, Manufacturing and Re-Test / Expiry Dates For Active Pharmaceutical Ingredients And Intermediates
5.1.4 The Batch Number shall be entered in each page of BPCR.
5.1.5 Manager-Quality Assurance or his deputy shall issue BPCR which is stamped as “ISSUED BY” in blue ink on first page bottom corner towards right hand side along with signature and date.
5.1.6 QA shall hand over the BPCRs along with Raw Material Issuance Record (two sets) to Production department.
5.2 Issue of Partial / Additional Pages of BPCR
5.2.1 Production department shall raise the request in the format as per given in Annexure – II for Partial BPCR.
Example.: (When pages of earlier BPCR are spoiled by oil / color etc or torn fully).
5.2.2 Manager QA or his nominee shall approve the partial BPCR request. On receipt of approved request for Partial BPCR, the photocopies of the requested pages from the relevant “Documentation cell copy” are taken and issued.
5.3 Movement of BPCR
5.3.1 Production personnel shall receive the BPCR along with Raw Material Issuance record (two sets) from QA.
5.3.2 Production personnel shall forward the Raw Material Issuance record (two sets) to Ware House after getting approval from Manager- Production or his deputy.
5.3.3 Ware House shall dispense the Raw Materials, enter the details in Raw Material Issuance Record (two sets) and retain one set with them and other set shall be sent back to Production department.
5.3.3.1 The details like Gross weight, Tare weight, Net weight and Analytical Reference Number etc., are entered in the Raw Material Issuance record.
5.3.4 The Production department shall maintain the BPCR till all the manufacturing steps are completed.
5.3.5 Relevant entries shall be made by Production department in the BPCR at the time of operation. Line clearance during manufacturing is given by IPQA personnel wherever applicable.
5.3.6 Production Head or his nominee shall review the completed BPCR and forward it to QA along with “Sampling Request” and “Batch Release and Transfer Slip” as per the format given in Annexure- III of SOP Batch Release
5.3.7 QA shall check the BPCR and forward “Sample Request” and “Production Release and Transfer Slip” to QC for sampling.
5.3.8 QA shall review the completed BPCR from Production as per the BPCR Review Checklist (Annexure – I of Batch Release.
5.3.9 QA shall return the BPCR along with BPCR Review Checklist to Production department if any discrepancies are observed.
5.3.10 Production department shall send back the completed BPCR to QA after corrections as per the observations made by QA.
5.3.11 QA personnel shall counter check the corrected BPCR.
5.3.12 QC shall send “Certificate of Analysis (COA) / Analytical Report” and “Batch Release and Transfer Slip” to QA.
5.3.13 QA personnel shall check the analytical parameters as per the check list (Annexure –II of Batch Release) and forward the completed BPCR along with COA / Analytical report to Manager QA for his review.
5.3.14 Manager -QA or his deputy shall release the batch.
5.4 Cancellation of Issued BPCR
5.4.1 If the BPCR is not executed for any reason the BPCR shall be returned to the Manager –QA.
5.4.2 The cancellation details shall be entered in BPCR Issue and receipt record (Annexure- III). The cancelled BPCR shall be destroyed by shredding.
5.5 Storage and Destruction of Completed BPCR
5.5.1 The completed BPCR is stored in the Documentation Room.
5.5.2 Every BPCR shall be retained for one year after the expiry date of Batch.
5.5.3 After completion of retention period, the BPCR shall be destroyed as per SOP Batch Release
END OF DOCUMENT
Production, control records, cancellation storage, issue
