BMR and BPR Preparation, Purpose:
BMR and BPR Preparation, The purpose of this SOP is to define those details that need to be specified in, BMR & BPR to enable consistent routine manufacture and Packaging.
BMR and BPR Preparation, Scope:
This SOP is applicable for preparation of BMR and BPR of XX Pharmaceuticals Limited.
Definition of Terms:
[][]BMR: Batch Manufacturing Record
[][]BPR: Batch Packing record
Responsibilities:
The roles and responsibility are as follows:
Senior Executive, Product Development
[][]Preparation of BMR and BPR following the SOP.
[][]Preparation and revision of validated BMR and BPR after completion of validation
[][]Preparation and timely review of the SOP.
Assistant Manager, Production
[][]Review of the BMR and BPR
[][]General manager, Plant
[][]Review of the BMR and BPR
Manager, Quality Assurance
[][]Approve the BMR and BPR
[][]Approve the SOP against XX Pharmaceuticals Ltd. master documents and current regulatory requirements.
[][]Implementation of the SOP.
Procedure:
[][]Procedure for preparation of Batch Manufacturing record (BMR)
[][]Select and confirm that the name and strength of the product and all the parameters related to BMR is correct.
[][]Follow the following procedure while preparing BMR
[][]A4 size paper
[][]Page orientation will be landscape
[][]Keep the top margin 0.2”, bottom margin 0.2”, Left margin 0.5”, Right margin 0.5”, gutter 0 and gutter position at left
[][]Keep the header and footer 0.2” from the edge
[][]Use Arial font
[][]Font size will be 10 unless or otherwise specified.
[][]Use Bold Capital letters inside third bracket for headings like Dispensing, Granulation etc
[][]Use Bold Capital letters for heading like Check before dispensing, Check before sieving, manufacturing instruction etc. Roman numerical numbers should be followed with the heading.
[][]Use normal Bold letters for any highlighting process
[][]Use arithmetic numerical numbers for all manufacturing instructions
[][]Use border line of two horizontal lines at every page.
[][]Include a table for prepared by, checked by and verified by after completion of all checking steps.
[][]Follow the following for header and footer
[][]Company logo will be standard sized at the top left corner of the page.
[][]Company Name will at the middle with all Capital letter, Bold and with font size 14.
[][]Company address will be at the middle with bold letters of font size 10.
[][]Place Batch Manufacturing Record at the middle in between company name and logo and signatory separated by two double lined horizontal line.
[][]Batch Manufacturing Record will be at the middle with all capital bold letters of font size 12.
Heading on the header will be
[][]Product Name
[][]Product Code
[][]Batch Size
[][]Version No
[][]Batch No
[][]Mfg Date
[][]Exp Date and
[][]Page number.
[][]With normal bold letters of font size 10.
[][]Product name will be normal bold letters of font size 12
[][]Signatory will have one prepared by, one checked by, three reviewed by and one approved option with normal, bold letters of font size 10.
[][]Designation, Department and date option of signatory will be of font size 10.
[][]Use effective date, revision date and revision history in first page.
[][]State a precaution (where applicable) and checking step prior to starting of any processing steps.
[][]Give a title for each stage such as room condition, machine setup etc. Title will be normal Bold letters with font size 10.
[][]Write all the instruction chronologically, sequentially, logically and in a clear way so that everyone can understand easily.
[][]Provide IPC parameters specification and checking sheet where applicable
[][]Provide a container summary record space at the end of the steps like compression and coating.
[][]Keep a reconciliation stage after each processing steps (eg. Granulation, compression etc.)
[][]Provide documents checking option of production and quality assurance head after completion of all stages.
Procedure for preparation of Batch Packing record (Primary Packing)
[][]Select and confirm that the name and strength of the product and all the parameters related to BPR is correct.
Follow the following procedure while preparing BPR
[][]A4 size paper
[][]Page orientation will be landscape
[][]Keep the top margin 0.2”, bottom margin 0.2”, Left margin 0.5”, Right margin 0.5”, gutter 0 and gutter position at left
[][]Keep the header and footer 0.2” from the edge
[][]Use Arial font
[][]Font size will be 10
[][]Use Bold Capital letters inside third bracket for headings like Primary Packaging
[][]Use Bold Capital letters for heading like material requisition, line clearance etc. Roman numerical numbers should be followed with the heading.
[][]Use normal Bold letters for any highlighting process
[][]Use arithmetic numerical numbers for all checking parameters
[][]Use bullet point for all checking options
[][]Use border line of two horizontal lines at every page.
[][]Include a table for performed by, checked by and verified by after completion of all checking steps.
[][]Follow the same procedure as described for header for BMR in case of BPR also
[][]Keep effective date, revision date and revision history in the first page of the BPR
[][]Put the following option in the BPR
[][]Material requisition sheet
[][]Line clearance record
[][]Machine setup section
[][]Record keeping action for setting up the machine
[][]In process checking parameters and record keeping option
[][]Destruction record keeping option
[][]Reconciliation stage after Packaging
[][]Provide documents checking option of production and quality assurance head after completion of all stages.
[][]Procedure for preparation of Batch Packaging Record (Secondary Packing)
[][]Select and confirm that the name and strength of the product and all the parameters related to BPR is correct.
[][]Follow the same page margin specification as were in the batch packaging record
[][]Follow the same procedure as described for header and footer for BMR in case of BPR also
[][]Keep effective date, revision date and revision history in the first page of the BPR
[][]Put the following option in the BPR
[][]Material requisition option
[][]Line clearance option
[][]Item checking before packaging option
[][]Machine setup option with record
[][]In process checking parameters and record keeping option
[][]Item check after packing
[][]Sampling summary
[][]Packaging material destruction record
[][]Reconciliation record
[][]Yield calculation option
[][]Batch reconciliation option
[][]Finished product transfer record
[][]Provide documents checking option of production and quality assurance head after completion of all stages.
Procedure for preparation of Batch Packaging Record (Physicians Sample)
[][]Follow same procedure as Batch Packing Area with the following exception
[][]Specify Physicians sample at the header of the BPR
[][]Do not keep any batch reconciliation and material transfer record in the BPR.
Annexure:
Annexure – I: Format of Batch Manufacturing Record (BMR)
Annexure – II: Format of Batch Packing Record (Primary Packaging)
Annexure – III: Format of Batch Packaging Record (Secondary Packaging)
Annexure-IV: Format of Batch Packaging Record (Physicians Sample)