Standard Operating Procedure For Movement of Batch Documents
1.0 Purpose :
To provide guidelines for movement of batch documents, Batch Manufacturing Record (BMR) and Batch Packaging record (BPR).
2.0 Scope :
This procedure is applicable for the movement of batch documents, Batch Manufacturing Record (BMR) and Batch Packaging record (BPR) of all the products manufactured at [Company name].
3.0 Responsibility :
Manager Manufacturing/ Packing : To monitor the Activity.
Head – QA: Monitoring the effective implementation
4.0 Definition:
Not Applicable
5.0 Procedure :
5.1 On receipt of requisition from Production Dept., BMR & BPR shall be issued to Production, by QA, as per respactive SOP for issuance of BMR and BMR.
5.2 Manufacturing supervisor / officer shall handover the BMR to Stores for dispensing of raw materials.
5.3 Based on Production Order sent by Manager Mfg., warehouse person shall take a printout of Formulation order (for raw materials) for the particular batch from SAP system. This Formulation shall be authorized by Manager / designee Manufacturing prior to commencing dispensing activities.
5.4 The following steps shall be followed in the case of manual entry.
5.5 After the completion of Dispensing, Officer Stores shall return the BMR along with Formulation order and dispensed raw material to the Manufacturing Supervisor.
5.6 After completion of manufacturing activities, Manufacturing supervisor shall forward the Test Request Form along with the “Technical Information Sheet , which is attached to the BMR through QA to QC for analysis of Blend.
5.7 After the completion of analysis, QC person shall record the results on the TI sheet and the TRF and take the signature of Assistant Manager or Officer QA and return it to IPQA personnel.
5.8 After receiving the Approved TI sheet and the Test Request Form (TRF), the IPQA personnel shall attach the same in the respective BMR.
5.9 After completion of compression activities, Manufacturing supervisor shall forward the Test Request form (TRF) along with the “Technical Information Sheet (TI Sheet), which is attached to the BMR through QA to QC for analysis of the core tablet.
5.10 After the completion of analysis, QC person shall record the results on the TI sheet and the TRF and take the signature of Assistant Manager or Officer QA and return it to IPQA personnel.
5.11 After receiving the Approved TI sheet and the TRF, the IPQA personnel shall attach the same in the respective BMR.
5.12 After completion of coating activities (if any), Manufacturing supervisor shall forward the Test Request form (TRF) along with the “Technical Information Sheet (TI Sheet), which is attached to the BMR through QA to QC for analysis of the coated tablet.
5.13 After the completion of analysis, QC chemist shall record the results on the TI sheet and the TRF and take the signature of Assistant Manager or Officer QA and return it to IPQA personnel.
5.14 After receiving the Approved TI sheet and the TRF, the IPQA personnel shall attach the same in the respective BMR.
5.15 While in case of entry done in LIMS, the printed TI sheet shall be attached with respective stage.
5.16 In the event of requirement of additional material, Manufacturing Supervisor shall issue an “Additional Material requisition” to Officer Stores through QA and it shall be attached to the respective BMR.
5.17 Manufacturing Person shall review the BMR, reconcile the yield, affix his signature and forward the it to IPQA personnel.
5.18 The BPR received by packaging supervisor from QA shall be attached to the same file holding the respective Batch manufacturing record
5.19 Packaging supervisor shall handover the Batch record (BMR and BPR) to Stores for dispensing of packaging materials.
5.20 Based on Purchase Order send by Manager – Pkg, warehouse person shall take a printout of Packaging Order (for Packaging materials) for the particular batch from SAP system. This Packaging Order shall be authorized by Manager packaging prior to commencing dispensing activities.
5.21 After the completion of Dispensing, warehouse person shall return the Batch record along with the Packaging Order and dispensed packaging material to Packaging Supervisor.
5.22 In the event of requirement of additional Packaging material, Manager Packaging will issue an “Additional Material requisition” to warehouse person through QA and attached to the respective batch record.
5.23 If Packaging materials have to be returned to Stores, Manager Packaging will return the same along with “Credit Material Return” slip through QA and the same shall be attached to the respective Batch Record.
5.24 After completion of the Packaging activities the packaging supervisor shall intimate the IPQA personnel. Then IPQA shall forward the Test Request form (TRF) to QC for analysis of Finished Product.
5.25 The packaging supervisor shall reconcile the yield, the Manager shall check the BPR.
5.26 Manager Packing shall check the BPR affix his signature and forward it to IPQA personnel.
5.27 After receiving the certificate of Analysis along with the TRF from QC the IPQA personnel shall attach the same in the respective batch Record.
5.28 IPQA personnel shall review the BMR & BPR and affix their signature on the covering page at the place marked “ Reviewed by QA” and record the date of review.
5.29 The particular batch shall be released for dispatch after Manager – QA sign on the BMR & BPR and issues a Batch Release Certificate to Finished Goods Store.
6.0 Frequency:
As and when batch is manufactured and packed
7.0 Formats:
Not Applicable
