sop for Preparation of BMR and BPR

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sop for Preparation of BMR and BPR

1.0 Objective
1.1 To define the procedure for preparation, issuance, control and retrieval of Master BMR and BPR.
2.0 Purpose and Scope:
2.1 This SOP shall be followed with the objective to prepare , issue, control and retrieval the batch records in correct way such that the GMP operations involved in the Production and packing of drug products are documented free of errors, issuance is controlled, retrieval is easy so that the history of a dug product batch is traceable whenever required.
2.2 This SOP is applicable for Preparation, Issuance, Control and Retrieval of Batch records at ABC Copany.
3.0 Responsibilities:
3.1 User department chemist/officer shall be responsible for preparation of Master Batch Manufacturing and Batch Packaging records of a new product as well as revising the Master batch Records whenever the changes are applied to particular product through DCR.
3.2 User department manager or designeeshell is responsible for reviewing of Master Batch Manufacturing and Batch Packaging records.
3.3 Head Production or designee shall be responsible for Reviewing of Master Batch Manufacturing and Batch Packaging records.
3.4 Manager QA or designee shall be responsible for review and Approving of new/revised Master batch manufacturing records and packing records.
3.5 Quality Assurance Documentation cell shall be responsible for Coordination with Production and Packaging department in preparation and revision of Batch Records.
3.6 Quality Assurance Manager shall be responsible for the inactivation of existing and reactivation of new Master batch manufacturing record/packing record to an active status.
3.7 Quality Assurance chemist/officer shall responsible for issuing all production batch records form approved Master batch records.
3.8 Quality Assurance Chemist/Officer shall be responsible for ensuring that no batch record is issued from Master batch record that are on HOLD or Inactivated and are not listed n the active product list maintained by Quality Assurance without prior approval from QA manager.
3.9 Quality Assurance Chemist/Officer shall responsible for compiling and destroying all canceled records at the end of each month.

Documents and formats:

Sr. No.	Document Title
i.	BMR & BPR Hold/ Inactivation Notification.
ii.	Requisition for Issuance of BMR & BPR
iii.	Requisition For Additional Pages Issuance of BMR/BPR
iv.	BMR/BPR Issuance and Retrieval Record
v.	BMR/BPR Issuance and Retrieval Record for P to P & LL Products
vi.	List of BMR/BPR
vii.	Addendum for List of BMR/BPR
viii.	Batch Transfer Packing Request Format
ix.	Batch Manufacturing Record (Capsules)
x.	Batch Packing Record (Capsules)
xi.	Batch Manufacturing Record (Tablets)
xii.	Batch Packing Record (Tablets)
xiii.	Batch Manufacturing Record (External)
xiv.	Batch Packing Record (External)
xv.	Batch Manufacturing Record (Liquid0
xvi.	Batch Packing Record (Liquid)

5.0 Materials, Equipment and Definitions:
5.1 Materials:
5.1.1 A4 size Paper
5.2 Equipment’s:
5.2.1 Computer and printer
5.3 Definitions:
5.3.1 Batch Manufacturing Records: The GMP Document which is printed in approvedinhouseformat intended to be used for recording the inline data/information during the GMP operations involved in packing of drug products.
5.3.2 Bath Packing Record: The GMP document which is printed in approved in house format intended to be used for recording the inline data/information during the GMP operations involve in packing of drug product.
5.3.3 Customer Specific Batch Record: The master Batch Manufacturing Records and Master batch packing records which are provided by the customer for specific product brand and shall b issued as it is in Controlled Copy for batch processing activities for that specific drug product are termed s Customer Specific Batch Records.
5.3.4 Master Copy: The paper copy of the originalproved Master Batch Manufacturing Record with original signs of the Author, Reviewer, Approver and Authorizer stamped in red inks “Master Copy” on each page is termed as Master Copy.
5.3.5 Usage Copy: The photocopy of the Master Copy printed on the A4 sheet and stamped in green ink as “Usage Copy” on each page is termed as Usage Copy.
5.3.6 Obsolete Copy: The superseded master Copy Stamped with OBSOLETE COPY in red ink at middle of each page.
Note: Obsolete copy of the batch record shall not be issued for the current products batches and Obsolete copy hall be retained as per SOP “Document and Data Control”
5.3.7 Master Formula Record (MFR): The GMP document which is describing the base formula of dispensing and compounding the drug –product and the instruction for processing and Packaging alone with the pharmacopoeia status and test specification of raw materials, intermediates, packing materials and finished products.

6.0 Procedure:
6.1 Preparation of a Mater batch manufacturing record:
6.1.1 Preparation of New BMR/BPR:
6.1.1.1 Chemist/Officer Production shall prepare the draft BMR/BPR based on the Technology Transfer product and PIF & submit to their Head and After reviewing the draft BMR/BPR by QA, it hall be hand over to Production department or final printout and signing of BMR/BPR.
6.1.1.2 After reviewed by production, BMR/BPR shall returned to QA for final approved by Manager QA or designee.
6.1.1.3 After “Approved from Manager QA or designee, BMR/BPR shall forwarded to QA Chemist/Officer.
6.1.1.4 QA Chemist/Officer hall make this final signed copy as master by stamping with “MASTER COPY” at right side top corner of each page.
6.1.1.5 Product Batch Records: Following points shall be covered while preparing the first page of BMR.
6.1.1.5.1 Department
6.1.1.5.2 Product Name
6.1.1.5.3 Batch Number
6.1.1.5.4 BMR Number
6.1.1.5.5 Effective Date
6.1.1.5.6 Superseded number
6.1.1.5.7 Page Number
Approval list: Shall contain the text boxes for:
6.1.1.5.8 Designations of Author, reviewer, approver,
6.1.1.5.9 Names of Author, reviewer, approver,
6.1.1.5.10 Signatures of Author, reviewer, approver,
6.1.1.5.11 Dates of preparations, review, approval,
NOTE: Authorization of customer shall be taken if required.
Product Information:
6.1.1.5.12 Generic name
6.1.1.5.13 Label Claim
6.1.1.5.14 Primary Packing Material
6.1.1.5.15 Shelf Life
6.1.1.5.16 Storage Condition
6.1.1.5.17 Manufacturing License Number
6.1.1.5.18 Batch No.
6.1.1.5.19 Theoretical/Standard Batch Size
6.1.1.5.20 Actual Batch Size
6.1.1.5.21 Mfg. Date
6.1.1.5.22 Exp. Date
6.1.1.5.23 BMR Issued By (Sign/Date) QA
6.1.1.6 Following points shall b covered (but not limited to) while preparing the BMR and content of BMR shall be as per process requirement of respective product.
6.1.1.6.1 Table of content
6.1.1.6.2 Specimen signatures of person involved in BMR.
6.1.1.6.3 List of Equipment
6.1.1.6.4 Calculation sheet for API
6.1.1.6.5 Dispensing of API/Excipients/PPM
6.1.1.6.6 Cleaning of manufacturing equipment’s.
6.1.1.6.7 Manufacturing Process.
6.1.1.6.8 Manufacturing/blending/filling/sealing process
6.1.1.6.9 Batch yield/final reconciliation
6.1.1.6.10 Primary packing material reconciliation
6.1.1.6.11 Abbreviation
6.1.1.7 Following points shall be covered (but not limited to) while preparing the BPR and content of BPR shall be as per packing requirement of respective product.
6.1.1.7.1 General information
6.1.1.7.2 Table of content
6.1.1.7.3 General instructions for packing
6.1.1.7.4 Secondary packing materials details
6.1.1.7.5 Precautions for packing materials issuance
6.1.1.7.6 Excess Material Requirement/Return
6.1.1.7.7 Packing operation instructions
6.1.1.7.8 Line Clearance for Carton Coding
6.1.1.7.9 Equipment’s/ machine details
6.1.1.7.10 Line clearance for packing operation
6.1.1.7.11 Wok allotment
6.1.1.7.12 In Process Checks of Packing Materials
6.1.1.7.13 Process Interruption/ Breakdown of Machine Report
6.1.1.7.14 Daily Packing and BSR Transfer Record
6.1.1.7.15 Printed Packing Material and Stereo Destruction Record
6.1.1.7.16 Secondary Packing Material reconciliation
6.1.1.7.17 Accountability Record
6.1.1.7.18 Batch Reconciliation Record
6.1.1.7.19 Batch Deviation Report
6.1.1.7.20 Quality Assurance department
6.1.1.7.21 Checklist
6.1.2 Revision of existing Master batch manufacturing record:
6.1.2.1 Production department proposes revision to existing BMR/BPR and initiate Document Change Request Form.
6.1.2.2 Filled Document Change Request form to be submitted to QA fo approval.
6.1.2.3 After QA Head approval on Document Change Request, Chemist/Officer Production hall make the approved changes in the BMR/BPR and then submits the revised draft copy of BMR/BPR to the QA department for review. After reviewing the draft BMR/BPR by QA, it shall be handed over to production department for final printout and sighing of BMR/BPR.
6.1.2.4 After approval by production, the revised BMR/BPR hall returned to QA for final authorization by Manager QA or designee.
6.1.2.5 After “Authorization” from Manager QA or designee, the revised BMR/BPR shall forwarded to QA Chemist/Officer.
6.1.2.6 QA Chemist/Officer shall make this final signed copy as master by stamping with “MASTER COPY” at right side top corner of each page.
6.1.2.7 QA Chemist/Officer shall obsolete master copy of previous version of BMR/BPR by stamping obsolete with red ink at the middle of each page.
6.1.2.8 QA chemist/Officer shall check if any batch record ha ben issued but not executed for the product; if so, the batch record shall be recalled and BMR/BPR shall be reissued.
6.2 Inactivation/Hold of an existing BMR/BPR:
6.2.1 QA maintains an active BMR/BPR listing.
6.2.2 QA determines that an existing BMR/BPR is to be removed from the active BMR/BPR file or placed on hold.
6.2.3 QA records the reason for hold/inactivation of an active BMR/BPR on the BMR/BPR Hold/Inactivation Notification Format.
6.2.4 QA list outs any issued batches, if applicable for that product on Format NO. BBL/QA/SOP/002/F1/00
6.2.5 QA removes the master BMR/BPR folder from the active BMR/BPR file, place Format No. BBL/QA/SOP/002/F1/00 on it and places the BMR/BPR in the QA inactive BMR/BPR file or places on hold.
6.3 Release from Hold/Reactivation of an BMR/BPR
6.3.1 QA determines that an active master BMR/BPR is to be reactivated to the active BMR/BPR file or released from hold.
6.3.2 QA performs a review of the applicable areas:
6.3.2.1 Raw material
6.3.2.2 Equipment
6.3.2.3 In-Process testing
6.3.2.4 Formulation
6.3.2.5 Finished product testing
6.3.2.6 Validation
6.3.2.7 Packaging
6.3.3 A copy of the completed review shall be maintained by QA.
6.3.4 QA records on Format No. BBL/QA/SOP/002/F1/00 the reason the BMR/BPR shall being released from hold o reactivated.
6.3.5 Filled Format No. BBL/QA/SOP/002/F1/00 along it the BMR/BPR shall forward to QA Had for final approval.
6.3.6 If any batch has been issued and not yet used, they shall be recalled and the revised Batch records re-issued.
6.3.7 QA Chemist removes form (HOLD) from the BMR/BPR and places the BMR/BPR in the active file.
6.4 Issuance of BMR/BPR:
6.4.1 Production officer/Executive shall fill in the product details in the BMR/BPR Issuance requisition Format No. BBL/QA/SOP/02/F2/00 and for the issuance of P to P and LL product BMR/BPR, Production officer/Executive shall fill the product detail in the format No. BBL/QA/SOP/002/F5/00.
6.4.2 On receiving of BMR/BPR requisition on the Production department, A shall photocopy from “MASTER COPY” of BMR/BPR and each page of BMR/BPR shall be stamped with “USAGE COPY”.
6.4.3 Chemist/Officer quality assurance shall issue the BMR/BPR with sigh and date.
6.4.4 QA officer/Executive shell issue the batch number as per SOP Batch numbering system (BBL/QA/SOP/002).
6.4.5 QA officer/Executive shall issue the line clearance checklist of respective stage along with batch record.
6.4.6 Officer/Executive Quality assurance h to sigh and date in the specified issuance columns in the BMR.
6.4.7 Issuance record of BMR/BPR shall be maintained in the Batch Issuance/Retrieval register at BBL/QA/SOP/00
6.4.8 Additional pages of BMR/BPR shall be issued after receipt of requisition which shall be requested by section head user department and authorized by QA. A justifiable reason for the additional pages requirement shall be detailed in the requisition.
6.4.9 The requisition for additional pages f the BMR/BPR shallbe de through the form as per Format No.
6.4.10 The filled requisitions for BMR/BPR shall be submitted to QA department for final archiving and storage.
6.4.11 In case of cancellation of a batch due to unforeseen reasons, the issued copy hall be returned back o QA and the same hall be treated as ‘cancelled’.
6.4.12 The cancelled copy shall be destroyed with the authorization of Manager QA and fresh copy with same batch number (cancelled batch number)shall be issued with appropriate batch details on fresh equipment given as per Format II

If next sequential batch number has already been issued, fresh batch number shall be allotted to cancelled batch.
6.4.13 For the stability batches, at the time of BMR/BPR issuance, Officer QA hall stamp the “Stability Batch” in blue color on top of font page of the BMR/BPR.
6.4.14 For Process Validation batches, at the time of BMR/BPR issuance, Officer QA hall stamp the “Process Validation Batch” in blue color on top of font page of the BMR/BPR.
6.4.15 In case any manufactured batch has to be packed for more than on market (If Primary Packing Material, API vendor and formulation) then manufactured batch shall be considered as mother batch and child batches for different market shall be issued with next sequential batch numbers and required information of mother batch shall be filled by production department as per format QA001/F8/00 and shall be forward to QA department.
6.5 Numbering System of BMR/BPR:
6.5.1 The numbering system of BMR/BPR is A/B/C/D/E
Where A stands for organization code, i.e. TP (Talwar Pharma)
B stands for department code, i.e. PD for Production department
C stands for name of Section, i.e. C for Capsules section. O for Ointment section
D stands for name of document, i.e. BMR for Batch Manufacturing Record and BPR for Batch Packing Record.
E is serial no of document i.e. 001, 002 and so on.
Example is P/PD/C/BMR/001
BMR/BPR number shall be maintained by QA chemist/officer as per format QA01/F6/00 and printout of List of BMR/BPR shall be taken quarterly and master copy of list of BMR/BPR shall be archived in QA department.
6.5.2 On introduction of new product/brand, QA shall assign the BMR/BPR number as per format VII “Addendum for Lit of BMR/BPR” and this addendum shall be included in format on quarterly basis.
6.6 Retrieval of batch record:
6.6.1 All completed batch records including process validation batches shall be stored under lock and key with restricted entry of authorized person of Quality assurance only.
6.6.2 Retrieval filled batch records for the Reference purpose shall be done only after receiving approved written requisition from the Head of concerned department and Manager-Quality assurance as per format QA01/F2/00 of SOP “Document and Data Control” (TP/QA/SOP/001).
6.6.3 On receiving back the completed batch record from the concerned department complete the entries in retrieved column by sigh and date.
6.6.4 Archive the documents in Quality assurance record room.