Procedure for Issue and Control of Batch Processing Record

1.0	PURPOSE To lay down the procedure for Issue & Control of the batch processing record which comprises of Batch Manufacturing Record and Batch Packing Record. .
2.0	SCOPE The scope of this standard operating procedure is to provide the system for Preparation, issue, retrieval, preservation and destruction of batch processing records.
3.0	RESPONSIBILITY Officer –Quality Assurance
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0	PROCEDURE
5.1 5.2 5.3 5.4 5.5 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5 5.6 5.6.1 5.6.2 5.7 5.7.1 5.7.2 5.7.3 5.7.4 5.8 5.8.1 5.8.2 5.8.3 5.8.4 5.8.5 5.8.6 5.8.7	On receipt of Master Manufacturing procedure from Corporate Quality Assurance prepare the BPR based on the master manufacturing procedure and Bill of Packing Material. Confirm the availability of license by entering license no & date. BMR shall be “Product code” specific and BPR shall be pack code specific. 5.4             The BPR are generated at location; the first copy shall be stamped   as “MASTER COPY” in green color on every page with date and sign. 5.5             ISSUE OF BATCH PROCESSING RECORD :                     BPR requisition from Production department shall be received in Batch Record Requisition Slip as per annexure II. 5.6             Check the requisition and verify the identity of the document required by referring the product code list. 5.7             Photocopy the required number of copies of BPR from master copy as per the requisition received. Stamp each page with “CONTROLLED COPY” with Blue ink on the right top of each page of BPR. 5.8             Write the details of batch number & batch size details on every page, issue by and issue date on the first  page of BPR. 5.9             Enter the details of batch number, date of issue, etc. in Batch Issuance log Book as per annexure I. ISSUE OF ADDITIONAL/REPLACEMENT PAGES: Receive the request of additional /replacement pages requirement with justification. Issue the pages as requested by stamping on each page with “CONTROLLED COPY” with Blue ink on each page of BPR. 5.15     CANCELLATION OF ISSUED BPR :              In any circumstances, issued BPR required to be returned or cancelled, the request shall be received by QA. 5.16     Once cancelled BPR when required to be issued again to manufacturing department or destroyed by shredding and records of the same shall be maintained in the register of Issuance, Retrieval & Storage of Batch Record.              Review the BPR as per the checklist provided in the BPR and counts the total number of page against the issued page.             Enter the details of “complete BPR receipt” in the register of Issuance, Retrieval & Storage of Batch Record. STORAGE OF BATCH PROCESSING RECORDS:                     After release of batch for sale, keep the complete set of Batch Processing Record (BPR & certificate of analysis) of the batch in file. Keep the files containing the Batch processing record in the record room. BPR shall be kept for five year. Keep product wise all the batch processing records. Keep the record room locked to ensure that documents are under control. The record room is to be accessed only to authorized personnel of QA.                     Issue of audited batch record from the record room: Person in need of an audited batch record will inform QA officer duly authorized by department Need for issue of the batch record, Officer –QA issue the same and after receiving verifying same for any damage and page missing and keep the Batch record back in the record room.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	BATCH ISSUANCE & RETRIEVAL RECORD	QA/027/F01-01
Annexure II	REQUISITION SLIP FOR ISSUANCE OF BPR	QA/027/F02-00

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
BPR						Batch Processing Record
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
Controlled office Copy No. 2							Head Production (Tablet) Deptt.
Controlled office Copy No. 3							Head Production (Liquid) Deptt
Controlled office Copy No. 4							Head Production (External) Deptt
Controlled office Copy No. 5							Head Production (Soap) Deptt
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

                                   

Annexure I

BATCH ISSUANCE & RETRIEVAL RECORD

Sr. No.

Date

Product Name

Batch No.

Mfg. Date

Exp. Date

Batch Size

Issued on

Issued By

Received By

Retrieved On

Retriev-ed By

Re-mark

Annexure II

REQUISITION SLIP FOR ISSUANCE OF BPR

FROM PRODUCTION DEPARTMENT

REFERNECE NO. _________________________________   DATE________________________

PRODUCT NAME_______________________________________________________________

BATCH NO.  __________________________________          BATCH SIZE__________________

MFG DATE    ________________________________             EXP. DATE____________________

REQUISITION RAISED ON____________________________________________________________

PRODUCTION                                                                                RECEIVED BY QA

Sign & date                                                                                     Sign & date