SOP for Preparation, issuance and control of Batch manufacturing record (BMR) and Batch packing record (BPR)
1.0 OBJECTIVE:
To lay down the procedure for preparation, issuance, retrieval, storage and destruction of Batch records [Batch manufacturing record (BMR) & Batch packing record (BPR).
2.0 SCOPE:
The scope of this standard operating procedure is to provide the system for preparation, issuance, retrieval, storage and destruction of Batch records at manufacturing site of [Company name].
3.0 RESPONSIBILITY:
3.1 Production personal for preparation of Batch records.
3.2 Quality assurance for approval, issuance, retrieval, storage and destruction of Batch records.
4.0 PROCEDURE:
4.1 Preparation of Batch records.
4.1.1 On receipt of Master manufacturing document from research and development (R & D) department, record the details as per Annexure I or receipt of copy of Technical Manufacturing Document during technology transfer due to transfer of product from other location. Check the details like availability of Mfg.licence and enter the necessary details in the respective column.
4.1.2 Issue the controlled copy of Master manufacturing document to production department for preparation of Batch records through issuance record as per document and data control SOP (Standard Operating Procedure).
4.1.3 In case of new product / technology transfer document received from R & D or other location department, initially BMR prepared by production personnel, checked by QA personnel and after that it is sent for checking by R&D department and than send to production head or his designee for checking. Finally the batch record is sent to Head QA or his designee for Approval.
For technology transfer technical document receive from other location BMR prepared & verified by production and Technology transfer representative or R&D personnel as case may be & approved by Head QA or his designee. While in case of BPR, records prepared on the basis of controlled copy Bill of Material & specification, production person prepare the documents & forward to QA for checking & final approval.
4.1.4 In case of commercial batches manufactured for Domestic/ Export market batch records BMR and BPR shall be prepared based on technical document received from R&D or Other Location and superseded BMR (if any) as per annexure VII and VIII respectively.
4.1.5 In case of ANDA batches either based on R&D development batch or site transfer / Approved ANDA site transfer, production personnel shall prepare BMR using format as per annexure IX.
4.1.6 In case of ANDA batches either based on R&D development batch or site transfer / Approved ANDA site transfer, production personnel shall prepare BPR using format as per annexure X.
4.1.7 The Batch records shall contains additional information other than the R&D document like work instruction/Instrument, Equipment traceability/ yield reconciliation at every appropriate phase, Revision history, Environmental condition monitor record, In process checks with frequency, Line clearance etc.
4.1.8 Finally the duly signed & dated Batch records submitted to Head QA for approval. NOTE: All signature and date to be entered in blue ink pen.
4.1.9 Master Batch records now shall be kept in QA department.
4.1.10 Any revision in Batch records shall be routed through change control program only.
4.1.11 If any corrections required to be done manually a ratification document shall be submitted to QA as per SOP on “correction of documentation error”.
4.1.12 Original ratification document shall be kept along with master Batch records for reference.
4.1.13 In case of Batch Packing Records (BPR) preparation, same procedure is to be followed but instead of MMD, controlled Bill of material and pack style & packaging instruction (specification) is to be referred.
4.1.14 Once the Head QA or his designee approves the Batch records the officer QA shall put the effective date with hand and than the Batch records are ready for use.
NOTE: Effective date to be entered in blue ink pen.
4.2 Issuance of Batch records.
4.2.1 Batch records requisition from production department shall be received as per Annexure II.
4.2.2 Check the requisition and verify the identity of the document required by referring the Product Code List. In case of export product “Export Order (EO)” shall be referred for customer specific requirement. In case of local product refer the planning copy from cooperate planning department.
4.2.3 Photocopy the required number of copies of Batch records shall be done from master copy as per the requisition received from production. Stamp each page of photocopy with “CONTROLLED WHEN IN RED” with red ink on the right top of each page of BMR/BPR.
4.2.4 Make the photocopy of EO & arrange it with photocopy of BMR and make ‘ √ ‘ against the expiry period if applicable for particular BMR/BPR (products).
4.2.5 Write the details of batch number on every page of Batch records (BMR/BPR)
4.2.6 On the first page of Batch records (BMR/BPR) issuer will sign & date in “ Issued by “ column.
4.2.7 Check the adequacy of packing pattern and identity of packing material to be used by comparing the bill of material with BPR, packing material specification, export order and also the product manufacturing license. Check for any special packing requirement in the export order specifically before issuing the BPR.( In case of EO write EO No. on space provided for EO No.
4.2.8 The batch records for validation / ANDA / commercial batches shall be prepared using the specimen format given in respective annexure.
4.2.9 “BATCH CONVERSION”
4.2.10 Batch conversion can be done in case of:
The Name of product remain same but is going to be packed in different packing code.
Conversion of the batch from generic name to Brand name.
Conversion of the batch from Brand name to generic name.
Change in batch numbering system based on the party requirement.
Change in the Brand name.
If any specific party requirements such as change in expiry of drug product, manufacturing and expiry date to be recorded / overprinted in nos. or only requirement of expiry date on drug product packing component.
Based on the quantity of product required as per the party with respect to standard batch size. The stage at which the batch Conversion can be raised
Batch conversion to raise at the time of before batch packing.
In case of batch manufactured but cancellation of export or local order.
The minimum requirement for generation of batch conversion.
Filled batch conversion note as per annexure-III
Ensure that the QC release for the batch is given. COA for that particular converted batch with the change in the test, batch number, or other changes if required is available.
Attach the photocopy of conversion note to BPR and file the original in the Conversion file.
4.2.11 Ensure the details of product conversion sheet as per Annexure III and issue the relevant BPR for execution.
4.2.12 Enter the details of batch number, date of issue, etc. as per Annexure V and then issue the control copy of authorized document to respective department.
4.2.13 If BMR / BPR are not executed within the month from the date of issue or due to any other circumstances, those Batch records shall be return along with return slip as per annexure VI with the reason for cancellation or return. Head QA or designee shall approve the same.
4.2.14 The retrieved un-executed/unprocessed Batch records shall be destroyed by shredding and records of the same shall be maintained in annexure V.
4.2.15 For additional pages requirement for Batch records, production shall send the dully filled format as per annexure IV to Head QA or designee with proper justification.
4.2.16 Head QA or designee authorized the same and forwards it to documentation department (QA) for issuance of the requested pages. The request copy shall be filed in respective file.
4.2.17 Documentation department person shall take photocopy of respective pages and put the stamp of “Controlled when in Red” and put sign and date on which the page issued.
4.2.18 After receiving of the batch record the IPQA department shall review it and send the same completed Batch records to documentation department. The officer in documentation department shall make entries in the register log. (Annexure V). The same document shall be stored for atleast one year after expiration period. Incase of the Batch records pertaining to the ANDA batches shall be stored for lifetime.
5.0 ANNEXURES:
Annexure – I Master Manufacturing Document/ Technology Transfer Document received from R & D / CQD / CQA / Other Location
Annexure – II BMR/ BPR Requisition cum issue slip
Annexure – III Approval of Conversion of Batch
Annexure – IV Requisition for Issuance of additional BMR/BPR pages
Annexure – V Issuance & Destruction of batch records
Annexure – VI BMR / BPR cancellation / return note
Annexure – VII Specimen of format Batch manufacturing record [Not provided here]
Annexure – VIII Specimen of format Batch packing record (Strip / Blister packing) [Not provided here]
Annexure – IX Specimen of format Batch manufacturing record for validation (ANDA batches/ Site transfer batches / common blend and strength there off) batches. [Not provided here]
Annexure – X Specimen of format Batch packing record (Bulk / Blister Packing) [Not provided here]
Annexure I Master Manufacturing Document/ Technology Transfer Document received from R & D / CQD / CQA / Other Location
Sr. No.
Date
Product
Ref. Document
Received from
Received By
Mfg.Lic.No. & date
Checked By
Remark
Annexure II Batch Manufacturing Record (BMR)/Batch packaging Record (BPR) requisition cum issuance slip
TO: QUALITY ASSURANCE DEPARTMENT
Please issue ______ No. (s) of Batch Manufacturing Records / Batch Packaging Records for Manufacturing / Packing for the product:___________________________________.
Product Code
Batch No.
Batch Size
EO No.
Pack Code
Pack Size
Qty. to be packed
BMR Issued on
BPR Issued on
Requested By
Approved By
Received By
Annexure III Approval for Conversion of batch
Date:
Product Manufactured as
Product Generic / Brand Name
Batch No.
Mfg. Date
Exp. Date
M/L / Code No
Theoretical / STD B. Size
Pack Code
Actual Quantity available (In nos.)
Production Officer
Packing Officer
Product to be converted as
Product Generic / Brand Name
Batch No.
Mfg. Date
Exp. Date
M/L / Code No
Quantity to be converted (In nos.)
Reason for conversion:
EO No/Local plan No. (If Any):
Country Name:
Packing Head
Production Head
QC Verification
Check list for release of a product from quality control department:
Testing of API done as per the required specification.
Additional tests to be performed (If any):
COA to be prepared for the converted batch (Yes/No)
In Opinion of QC from analytical aspect the batch can be /cannot be converted as requested.
Remark if any:
QC Officer
QC Head
Approval for conversion
Approved by QA Head
Authorized by Unit Head
Annexure IV Requisition For Issuance Of Additional BMR / BPR Pages
From :
To : QA Department
Please issue the additional pages as per listed bellow.
Sr. No.
Product
Name
Batch No.
Pack Code (if any)
Page No.
No. of Copy
Reason
Requested By
Approved By
Authorised By
Issued By
Annexure-V Issuance & Destruction of Batch Records
Product Name :
Product Code :
Sr. No.
BMR/BPR Requested On
Batch No
Batch Size
EO No. (If any)
Pack code
Issuance of
BMR
Issuance of
BPR
In case of Unprocessed BMR / BPR returned
Completed
BMR/BPR
Received
By / date
Destruction
of Batch records
After
Completion of retention period
Reason
BMR/BPR
received &
Destroyed By
Issued
on
Issued
By
Received By
Issued on
Issued
By
Received By
Annexure VI – BMR/BPR Cancellation / Return Note
Product
Pack Code
Batch No.
Batch Size
BMR/ BPR Issued on
Note No.
Reason for cancellation / Return of BMR/BPR:
Production Department/ Date
Authorised By/ Date
Unit Head
Remark if any:
Authorization for Cancellation by QA Head/ Date
Remark if any: