SOP on Issue, Receipt, Storage and Destruction of Batch Manufacturing Records
Objective : To lay down a procedure for issuance, receipt, storage and destruction of Batch Manufacturing Records.
Scope : This Standard Operating Procedure is applicable for the issuance, receipt, storage and destruction of BMRs of products being manufactured and issuance of BMR to Contract acceptor, if any, for the manufacture of the drug product(s) at contract manufacturing locations.
Responsibility : Officer /Executive – QA :shall be responsible for issuance, receipt, storage and destruction of Batch Manufacturing Records
Head – QA : shall be responsible for implementation compliance of the SOP
Abbreviations and Definitions
BMR : Batch Manufacturing Record; filled / unfilled controlled copy of Technical Directions along with other requisite forms / records, which reveals all the information of a batch of a product.
Procedure :
Issuance : The Respective Area Incharge-Production or his /her designee shall fill the form titled “BMR Issue Request Form” as per production planning.
Reference number on the BMR request form shall be assigned by officer/executive production personnel and shall be numbered as;
Reference number shall be assigned by nine alphanumeric characters as “AAXXXX/YY”.
Where AA denotes the block e.g. TB for Tablet section, LB for Liquid block.
“XXXX” shall denote the serial number of the BMR request number as 0001, 0002, 0003 and so on for that particular block.
“/“representing slash.
And finally “YY” represents the financial year as “25” for “2025 -2026”.
After providing all the relevant details in the “BMR Issue request form” Head-Production/ Designee shall verify the details and after approval shall forward the request to QA department for their evaluation.
Head QA/Designee shall approve/ disapprove the request with intimation to Production.
After approval of the request, Officer /Executive – QA shall arrange photocopy of the relevant documents which are the components of BMR.
Officer /Executive – QA shall assign Batch Number as per the SOP titled ‘Batch Numbering’ which shall be written by Hand/Machine on all the pages of relevance. Manufacturing and Expiry date for a certain batch having manufacturing date January 2025 and expiry date December 2027 shall be written as Jan.2025 and Dec.2027, all entries shall be comprise of first three letters of the month followed by full stop “.” (wherever applicable) and the respective year
Every page of the unfilled BMR shall carry an impression of QA stamp in blue colour with initials of the person issuing the BMR (on top of right hand side). Except for the manufacturing / expiry dates which shall be filled by production personnel, all other entries shall be filled by Officer / Executive – QA during the issuance of the BMR.
Officer / Executive – QA shall number every page of the BMR (on lower right hand side non-text part) with the help of Hand/Machine as 01, 02, 03, 04, and so on.
All the documents/ formats comprising the unfilled BMR shall be placed in a conventional spring file, before issuance to production. The BMR file cover shall be printed.
Plastic pocket folder(s) shall be attached in the BMR in order to place the Tags/Labels.
All the details of the issuing BMR shall be entered in the records titled “BMR Issuance Register”.
The unfilled BMR shall be sent to Head – Production or his / her designee and the receipt shall be obtained on record titled “BMR Issuance Register”, before receiving the BMR production personnel shall ensure the integrity of the BMR.
In case the batch shall not be executed for more than 45 working days, then the BMR of that batch shall be send back in QA by the Production personnel signed by Head-production or his/her designee with proper justification.
In case of any change in the production plan against any exigency like a change in market requirement or change in pack style, Section in-charge/ designee shall again re-send the “BMR Re-issuance request form” after filling all the details in format, again the same procedure for issuance of BMR shall be followed.
In case of spoilage of page/s in the BMR, the same shall be returned to the QA along with a request for re-issuance of a fresh copy either of the spoilt page/s on form titled “Requisition for Re issuance of BMR”.
Returned “Formats” and “BMR” shall be destroyed by QA department through paper shredder or by manual operations.
Officer /Executive – QA shall re-issue the required format/s of the BMR against the request forwarded by Production. Necessary corrections/ entries shall be made in the Batch Issuance Register.
The concerned production, stores, QC and IPQA personnel shall fill the unfilled BMR during the manufacture of drug product.
After completion, filled BMR shall be reviewed by Head – Production or his/ her designee and approval for batch release shall be given.
Head – Production or his/ her designee shall send the filled BMR to Head – QC / designee for further review and approval.
Head – QC or his/ her designee shall review the BMR and give his / her approval for final release and shall send the same to QA.
Receipt
The Officer /Executive – QA shall receive the BMR and verify for the total number of pages issued and received and the analytical record attached in the BMR as per form titled “BMR Index”. The information contained in the BMR shall be recorded as per the form titled “Batch Summary Record”.
*Note: Recording shall be done in computer system and Officer/ Executive- QA shall take the print (Product wise) at end of year or as and when required and same shall be signed off and kept in QA Documentation cell.
Head – QA or his/her designee shall review the BMR and give final approval for release.
Storage
All the released BMRs shall be filed and archived in Documentation Cell (QA), Product wise and as per Batch No.
The BMR(s) can be referred from Documentation Cell (QA). Personnel referring the BMR shall fill titled “Requisition of BMR(s) in QA Custody” and only after approval from Head-QA shall refer the filled BMR.
Destruction
In-charge, Documentation Cell – QA shall assess the due date of destruction of BMR(s) and prepare a list of BMRs at least twice a year as per the form titled “List of BMR (s) for Destruction” and forward list to Head – QA.
BMRs kept in QA custody for Destruction shall be destroyed as per following timelines:
BMRs of Domestic Market shall be destroyed after two years of expiry of product.
BMRs for Regulatory Market shall be destroyed as per contract signed off or after seven years from the date of release of product or whichever earlier.
BMRs of Optimization & Exhibit batches shall be destroyed after the product is approved from the respective Regulatory Authorities / or not more than seven years.
Head – QA shall allow the destruction of BMRs by signing in ‘List approved by’ column.
The BMRs for destruction shall be destroyed by incineration or using a paper shredder.