Standard Operating Procedure for Preparation, Issuance and Retrieval of Batch Record
1.0 Purpose :
To lay down a procedure for Preparation, Issuance and Retrieval of Batch Record.
2.0 Scope :
The scope of this SOP is to provide a procedure for Preparation, Issuance and Retrieval of Batch Record of Drug Product, which is manufactured at [company name]. Batch Record comprises of Batch Manufacturing Record (BMR) and Batch Packing Record (BPR).
3.0 Responsibility :
Production Person :
Preparation of the Batch Record (BMR and BPR)
Manager Production :
Checking of the Batch Record (BMR and BPR)
To return the executed and completed Batch Record (BMR and BPR)
QA Person :
To check the Batch Record (BMR and BPR)
To issue the Batch Record (BMR and BPR)
To retrieve the Batch Record (BMR and BPR)
R&D :
To check the BMR
Head QA:
To approve the Batch Record (BMR and BPR)
To ensure the compliance to procedure
4.0 Definition:
Not Applicable
5.0 Procedure :
• Whenever Master Formula Record (MFR) is revised, BMR or BPR or Both shall be revised as per requirement.
• Any changes required in recording format also lead to BMR and BPR revision.
• Production Person shall prepare the BMR and BPR on the basis of respective approved MFR of the Drug Product.
• BMR and BPR shall contain sequential steps of Manufacturing and Packaging respectively as stated in the MFR with provision of recording the activity, performing time and signature of the responsible Person.
• Preparation Procedure :
• Master BMR and BPR shall be prepared with text font style “Arial” and font size “11”.
• Following predetermined margin through template has been set for preparation of BMR/BPR.
Orientation: Portrait
Paper Margins: Top: 0.5” Bottom: 0.5” Left: 1.2” Right: 0.5”
Header: 0.5” Footer: 0.4”
Select option as ‘Mirror Margin’ in case of Preparation of BMR/BPR.
• Header of all the pages of BMR and BPR shall have “Company LOGO” on the left hand side.
Header shall also have a table having Batch Manufacturing Record (BMR) / Batch Packaging Record (BPR) , Brand Name (if applicable), Generic Name, Batch No., Issued On date, BMR/BPR Reference No., Revision No., Batch Size and Page No. Provision for mentioning Brand Name shall not be applicable to Batch Manufacturing Record (BMR).
• BMR/BPR Reference Numbering system [respactive organization will decide the numbering system]
• In case there is difference in Equipment, Area, Facility or Batch Size, Specific Country requirement a suffix shall be put at the end of the BMR Reference No. e.g. A, B, C….
• In case there is difference in Pack Style, Customer, Specific Country requirement, different batch size a suffix shall be put at the end of the BPR Reference No. e.g. A, B, C….
• “Revision No.” shall be assigned to each BMR / BPR, indicating the number of revisions the document has undergone. It shall be “00” when the document is prepared first time and subsequently as 01, 02….
• “Page Number” shall be assigned to each page of the BMR / BPR. The page number shall be in the form of 1 of X, 2 of X,… , X of X, where X = Total No. of Pages.
• All BMR / BPR shall bear address of the respective location at the bottom of the left hand corner of all pages and space for “MASTER COPY ……….” stamp.
Template specification are as below:
• For address of the respective location : Font : Times New Roman, Style : Regular, Size : 8, Color : Black.
• The first page of BMR shall have following details ;
(a) Description
(b) Label Claim
(c) Product Code No.
(d) BMR Effective Date
(e) Effective Batch No.
(f) Master Formula Ref. No.
(g) Shelf Life
(h) Master Formula Rev. No.
(i) Sign (Head QA)
(J) Month of Manufacturing
(k) Month of Expiry / Retest Month
(l) Batch commenced on
(m) Batch completed on
(n) Checked By
(o) Mfg. License No.
(p) BMR Issued By (QA) and Date
(q) BMR Received By (Manufacturing) and Date
(r) Filled BMR Reviewed By (Mfg) / Date
(s) Filled BMR Reviewed By (QA) / Date
(t) Filled BMR Retrieved By (QA) / Date
(u) BMR Prepared By (Manufacturing)
(v) BMR Checked By (Manufacturing, Quality Assurance & R&D),
(w) BMR Approved By (Quality Assurance)
• The first page of BPR shall have following details ;
(a) Description
(b) Label Claim
(c) Product Code No.
(d) BPR Effective Date
(e) Pack Size
(f) Effective Batch No.
(g) Master Formula Ref. No.
(h) Shelf Life
(i) Master Formula Rev. No.
(j) Sign (Head QA)
(k) Mfg. License No.
(l) Month of Manufacturing
(m) Month of Expiry / Retest Month
(n) Packing commenced on
(o) Packing completed on
(p) Checked By
(q) BPR Issued By (QA) and Date
(r) BPR Received By (Packaging) and Date
(s) Filled BPR Reviewed By (Pkg.) / Date
(t) Filled BPR Reviewed By (QA) / Date
(u) BPR Prepared By (Packaging)
(v) BPR Checked By (Quality Assurance & Packaging)
(w) BPR Approved By (Quality Assurance).
In case only Manufacturing Formula Record (MFR) is revised and no impact on BMR / BPR, write the MFR Revision No. can be updated on the BMR with sign and date.
• BMR shall have minimum (but not limited to) following details;
1 Front Page
2 General Instruction
3 Dispensing and Weighing Record
4 Calculation for Potency of Active Ingredient (if required)
5 Line Clearance Checks and reference of Operating and Cleaning Procedures
6 Manufacturing Activity
7 Technical Information (TI) Sheet for Blend Analysis
8 Compression (Initial Checks, In-process Checks, Weighing and Visual Inspection of Tablets)
9 Technical Information (TI) Sheet for Compressed Tablets Analysis
10 Coating (In case the product is coated) (Dispensing and Weighing Record, Solution Preparation, Milling, Filtration, Parameters for Coating and Method of Application)
11 In-process Record for Coating
12 Technical Information (TI) Sheet for Coated Tablets Analysis.
13 Destruction Record of the In-process Sample, Non-recoverable Material at every stage.
14 Yield Reconciliation as per the format given in the SOP at every stage (Granulation, Blending, Compression, Coating, Visual Inspection, Imprinting & Capsule filling)
15 BMR Revision History
In case of Sterile Dosage BMR shall have additional details ;
Decartoning of Vials.
Washing and Depyrogenation.
Cleaning and Sterilization Record for Manufacturing Vessels, Filtration Vessels, Filtration Assembly and Accessories
Bulk Solution Preparation
Filtration
Sterilization of Bung and Seals
Sterilization of grossary and Equipment required for Filling Activity
Record the Pre and Post Filter Integrity Test
Decartoning and transfer record of Pre-sterilized Plastic Containers into Controlled Area.
Analysis result details of Bulk analysis for before filtration bio load, chemical analysis and after filtration
Process Checks for Lyophilization (In case of Lyophilized Product).
Sealing of Vials, In-process Checks during Sealing
In process check to performed for coding and printing
Leak Testing of filled and sealed Product Container
Storage Condition Record for Under Quarantine Product before and after Packing.
Record of Visual Inspection of Finished Product
Destruction Record of the In-process sample, Non-recoverable material at every stage.
Yield Reconciliation at various stage such as depyrogenation, bulk solution, filling operation, visual inspection actual batch yield, vials/bottles/PFS (Pre filled Syringe), rubber stopper, Seals/caps and packaging activates.
BMR Revision History
• BPR shall have minimum (but not limited to) following details ;
1 Front Page
2 General Instruction
3 Container Loading Record
4 Packaging Order for Sales or PS (List of Packaging Materials with Item Code Numbers and Quantities required for the particular Batch Size)
5 Line Clearance Checks and Operating and Cleaning Procedure Reference
6 Packaging Instructions
7 In-process Record for Overprinting of Blisters, Cartons or Catch Covers and Shippers
8 Job Allocation Record
9 In-process Record for Packaging
10 Packaging out put details & Transfer slip record to FG Store.
11 Packaging material reconciliation record 6.1.16.
12 Destruction record of the in process sample, non-recoverable material at every stage. 6.1.16.
13 Yield reconciliation for the batch as per format given in the SOP.
14 BPR Revision History Sheet.
• Master BMR / BPR shall be printed on A4 Size White paper.
• Original BMR / BPR shall be stamped as “MASTER COPY” (In Green Ink) on the bottom right hand corner of all the pages. “MASTER COPY” shall be signed with date by QA person.
• QA Person shall write the “Effective Date” on which date the BMR / BPR is made effective.
• QA Person shall write the “Effective Batch No.” from which Batch No. the BMR / BPR is made effective. This is the first batch from which the new / revised BMR / BPR comes into effect. It shall be done on receipt of “BMR / BPR Requisition Note”.
• QA Person shall prepare Master List of BMR and BPR respectively. Following details shall be covered in the list:
(a) Product Name
(b) Batch Size
(c) Product Code
(d) BMR/BPR Ref. No.
(e) Rev. No.
(f) Obsolete Date
(g) Market
(h) Pack profile [In case of Master list of BPR]
• Master list of BMR and BPR shall be updated manually upon revision and inclusion of New BMR Reference No.
• Master list shall be revised whenever required and all the manual updation shall be included in the revised Master List.
• Issuance of BMR / BPR for Execution :
• “Manufacturing Person shall send “BMR / BPR Requisition Note” to QA Department giving details of the Batch to be manufactured.
• Packing Person shall send “BMR / BPR Requisition Note” to QA Department giving details of the Batch, Packing with respect to Sale / Physician Sample (PS).
• On receipt of “BMR/ BPR Requisition Note”, QA Person shall take required number of photocopies of the respective Master BMR / BPR and “Check-list for Review of Batch Record”.
• During issuance of BMR for sterile formulation the pages which need to be used in aseptic area shall be identify and the photocopy of the related pages shall be taken on autoclave paper for issuance.
• For sterile Dosage (Injectable), issue the format for intervention recording along with the issuance of batch record.
• On the first page of BMR / BPR, QA Person shall write the following details;
(a) Batch No.
(b) Manufacturing Month / Date
(c) Expiry Month / Retesting Month / Date
• The Batch No. & Issued Date shall be stamped in blue ink on all pages of photocopied BMR / BPR. The date shall be in the format of MMM-DD-YYYY.
• QA Person shall check availability of all pages of BMR/BPR and sign with date against “Blank BMR / BPR Issued By” and Recipient (Manufacturing / Packaging Person) shall check availability of all pages of BMR/BPR and sign with date against “Blank BMR / BPR Received By” on the first page of BMR/BPR.
• The issue of the BMR / BPR shall be recorded in the “BMR / BPR Issuance and Retrieval Record” (Register). The issuing Person (QA Person) and Recipient (Manufacturing / Packaging Person) of the BMR / BPR shall sign with date.
• QA Person shall put the BMR in a “Batch Record File” as per the defined colour codes for identification [To be defined by Coompany].
• Write the following details on the “Batch Record File”
(a) Product Name
(b) Batch No.
(c) Mfg. Date
(d) Exp. Date / (Retesting Date)
(e) Batch Size
• The “Batch Record File” shall be stamped as “PROCESS VALIDATION, SIGN., DATE” for “Process Validation” Batch, “CLEANING VALIDATION, SIGN., DATE” for “Cleaning Validation” Batch and “Stability Batch, Sign , Date” on the top right hand side corner.
• In case of “PACKING VALIDATION” the first page of BPR / Batch Record file shall be stamped as “PACKING VALIDATION, SIGN., DATE” on the top right hand side corner. Person issuing the record shall sign with date.
• When additional copy or pages are required due to additional requirement or spoilage of page(s), Manufacturing / Packaging Person shall raise a “Additional Page Requisition” by mentioning the reason(s) with sign of Production Head and send to QA.
• On approval by QA Head, QA Person shall take photocopies of the required pages in required number of the respective Master BMR / BPR.
• The photocopies of additional pages shall be stamped as “Additional Page No.” at the bottom of the pages and by putting date and sign in “Issued By : Quality Assurance”
• Batch No. shall be stamped / written manually on all additional pages.
• Additional Pages issued shall be recorded in “Additional Page Issuance Record” (Register).
• Spoiled pages of the BMR / BPR shall be preserved in the respective “Batch Record File”.
• If any error observed after approval of the master document (MFR/ BMR/ BPR) then the error in printed matters shall be corrected as per procedure given in the respactive error correction form.
• The impact of corrections in printed text matter shall be accessed by Manufacturing / Packing head and Head QA.
• The final approval shall be done only by Site QA head or his designee.
• Retrieval of Batch Record:
• On completion of entire Manufacturing and Packaging activity, Manufacturing / Packaging Person shall submit the executed Batch Record to the QA Department.
• QA Person shall review the BMR and BPR in all contexts.
• QA Person shall release the batch and transfer the Batch Record in to Documentation Storage Room.
• Incase the batch is cancelled due to any reason (e.g. Production Plan Change), the BMR / BPR shall be submitted to QA Department.
• QA Person shall write the “Cancelled” in the BMR / BPR Issuance and Retrieval Record” and destroy the same.
• Procedure to Made BMR and BPR Obsolete :
• On Revision of BMR / BPR, the previous version of BMR / BPR shall be made Obsolete after conforming the completion of manufacturing / packing of batch with older version of BMR/ BPR putting Stamp diagonally “Obsolete Copy for Reference Only” as per specimen format .
• First page of Obsolete document shall have sign and date on Stamp “Obsolete Copy for Reference Only”.
6.0 Frequency:
Batch record preparation: New Product, new pack profile, market extension.
Batch Record Issurance: For each manufacturing and packaging activities
7.0 Formats:
1 Format for BMR
2 Format for BPR
3 Format for HISTORY OF REVISION OF BMR/ BPR
4 Format for BMR/BPR Issue & Retrieval Register
5 Format for Additional Pages Requisition
6 Format for Additional Pages Issue Register
7 Format for Stamp “Obsolete Copy for Reference Only”
8 Format for Master List of BMR / BPR
9 Format for recording intervention during Aseptic Filling
10 Format for Yield Calculation
11 Format for Correction in Master Batch Record.
12 Format for Media Fill BMR .
Reference Guideline: