Pharmaceutical industries are involved in the manufacturing of drug products which are finally utilized by the patients due to this reason a great level of care & compliance is required at each level of manufacturing.
Documentation in the pharmaceutical industries is very important & is also a requirement of various guidelines & regulatory bodies like GMP & US-FDA.
Different types of documentation is carried out in pharmaceutical industries in different departments according to the requirement.BMR or Batch Manufacturing Record is one of the most important documents of the production area.
What Is a Batch Manufacturing Record (BMR)?
A batch manufacturing record or BMR is a document that contains instructions on who a batch will be manufactured.
A batch Manufacturing record or BMR is the controlled document which includes all the information & written instructions that must be followed step by step during the manufacturing of a batch.
A batch manufacturing record or BMR is a written record where every activity is documented that is performed during the manufacturing of the batch of a product.
Batch Manufacturing Record or BMR is a written document that contains the history of a specific batch of a product.
Other Names Of BMR?
Batch Manufacturing Record is also known as,
- Batch Processing Record (BPR)
- Batch Production Record (BPR)
- Batch Production & Control Record (BPCR)
Explanation
For manufacturing of any batch of a product the BMR is issued by the QA department & filled in the manufacturing area by the production officer.
BMR contains all the information regarding the manufacturing process along with the equipment used.BMR guides the operators & qualified persons on how a specific activity must be performed using a specific equipment as per described parameters.
Each performed activity is dualy signed by the operator who performed it & is cross-signed by the qualified person. In simple words, BMR records the real-time data of all the activities.
How Batch Manufacturing Record or BMR Is Issued?
According to the planning forecast the production department sets the manufacturing plan & generates the request for issuance of BMR & sends it to the QA department.
The quality assurance department has a master copy or master file of the all the BMRs and prints the specific BMR after giving a specified Batch number to that batch.
The QA department records the product name & batch number in the BMR issuance register or file & hands over the Batch manufacturing record to the production department after taking the initials of the person from production who is designated for BMR receiving.
The Production Manager reviews the BMR, Manufacturing, Expiry date & signs it.
QA manager also cross-signs it & this BMR or Batch Production Record is ready to use for the manufacturing process.
Components Of BMR?
A Batch manufacturing Record or BMR consists of different components and is divided into the following 2 main categories,
- Fixed Components
- Attachable Components
Fixed Components Of BMR
Fixed components of the Batch manufacturing record or BMR are those portions that are printed from the Master BMR & include the following,
- Batch Information
- Personnel Deployment Sheet
- Equipment Cleaning & Deployment Sheet
- Bill Of Material
- Critical Instructions
- Manufacturing Procedure
- Yield Portion
- Batch Reconciliation
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Batch Information
The first page of the BMR or Manufacturing Record contains important information related to the batch which is given below,
- Product Name
- Batch Number
- Registration Number
- Batch Size
- Manufacturing Date
- Expiry Date
- BMR Revision Number
- Brief Product Description Including,
- Dosage Form
- Shape
- Dimension
- Color
- Storage Condition
- Shelf Life
At the end of the first page, the authorized person signature space is provided which is signed by the Production Manager & QA manager.
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Personnel Deployment Sheet
The second portion of BMR contains the sheet where the names of all the personnel involved in various activities are mentioned with date & sign.
Example
If we take the example of BMR of the tablet manufacturing batch, then on the Personnel Deployment sheet we will mention the name of all the personnel & qualified staff involved at various stages like granulation, compression & coating.
The personnel deployment sheet acts as a traceability medium during the whole shelf life of the product & in case of any complaint from the market we can easily find out the personnel name involved in the manufacturing process of that specific batch.
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Equipment Cleaning & Deployment Sheet
The next part of BMR is the Equipment deployment sheet where the name of all the equipment is mentioned which are to be used during the manufacturing of a batch along with their cleaning procedure document number.
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Bill Of Material
The fourth part of the Batch production Record or BMR is the Bill Of Material. Bill Of Material is also known as BOM. Now let’s discuss what BOM is the BOM?
BOM is the sheet that includes the name of all the active pharmaceutical ingredients & excipients along with standard quantities.
On BOM a specified code of a specific material is also mentioned and space for the signature of a qualified person is also provided.
The pharmacist signs every ingredient on the BOM sheet after verifying its quantity & code.
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Critical Instructions
Before the start of manufacturing, any instructions can be mentioned in BMRÂ related to materials or equipment handling.
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Manufacturing Procedure
The main component of a BMR or batch manufacturing record is the manufacturing procedure.
It is the part of BMR where all the steps are written & which are followed during manufacturing.
In this portion, written instructions are given along with standard values & parameters, and actual data is filled in.
Each activity performed is signed by the operator & pharmacist.
In this portion time ranges are also mentioned for which a specific activity must be performed like blending time, drying time, etc.
Example
If we take the example of BMR of tablet manufacturing then its manufacturing process portion will include written instructions for,
- Granulation
- Compression
- Coating
Granulation
If we take an example of wet granulation then BMR will contain step-by-step instructions on how granules will be manufactured.
It will start from the weighing & sieving process to the dry mixing step to the kneading process to wet sieving & from wet sieving to drying, dry sieving & final blending.
In the granulation process, the following information is also mentioned,
- Sieve Number
- Mixing Time
- Kneading time
- Chopper speed
- Impeller blade Speed
- Wet Mill Speed
- Drying Time
- Drying Temperature
- LOD
- Final blending Time
Read Details
Wet granulation & Dry Granulation in pharmaceutical industries.
Compression
In the compression portion, all the instructions are given regarding how a batch will be compressed.
It includes the following,
- Tablet Dimension
- Punch Size
- Tablet Weight
- Tablet Hardness
- Tablet Friability
- Weight Variation
- Disintegration Time
- Tablet Thickness
Read Details
Stages and Mechanism of Tablet Compression.
Coating
The manufacturing process of tablet coating will contain step-by-step instructions on how a batch will be coated.
It includes the following,
- Method for Coating Suspension Preparation.
- Inlet Air Temperature
- Outlet air temperature
- Tablet Bed Temperature
- Spray rate
- Atomization air pressure
- Pan speed
- Peristaltic Pump Speed speed
Read Details
Technical Aspects of Tablet Coating Process.
7. Yield & Reconciliation
The yield is calculated after every major step like after drying, final blending, compression & coating.
At the end of batch manufacturing the reconciliation is done in which we calculate & write down the yield & line loss of every activity on a single page in terms of weight & numbers as well.
Read Details
Reconciliation in pharmaceutical industries.
Attachable Components
Attachable components are the papers or sheets that are attached to the BMR after receiving from other departments like raw material stores, QA, or QC departments & may include the following,
- Manufacturing order
- Check Lists
- Dispensing Labels
- Deviations
- Release Certificates
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Manufacturing order
A manufacturing order or MO is also known as dispensing order & it is the document that contains the recipe of the batch & all the ingredients are Dispensed in the raw material store according to this manufacturing or dispensing order.
It contains the following information
- Product Name
- Batch Number
- MO Number
- Batch Size
- List Of Materials
- Quantities Of Materials
- Lot Numbers Of Materials
- Code Of Materials
All the materials are dispensed according to the lots & quantities mentioned on the MO & are signed by the dispensing operator, store pharmacist & QA pharmacist.
This manufacturing order or dispensing order after batch dispensing is shifted to the production department along with the batch & is attached to the batch manufacturing record or BMR
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Check Lists
Before starting any activity in pharmaceutical industries the line clearance is awarded by the production & QA officer.
For line clearance a checklist is filled, signed & is attached to BMR. Different checklists are filled for different activities like,
- Dispensing Checklist
- Granulation Checklist
- Compression Checklist
- Coating Checklist
Read Details
Line Clearance in pharmaceuticals.
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Dispensing Labels
When a batch is dispensed in the raw material store, its ingredients are weighed in different polythene bags & each bag contains a specific dispensing label containing the following information,
- Product Name
- Batch Number
- Material Code
- Material Lot
- MO Number
- Ingredient Quantity
- Tare Weight
- Net Weight
- Gross Weight
After line clearance of manufacturing these labels are removed from the polythene bags at the time of usage & are attached to the BMR.
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Deviations
If any deviation occurs during the processing of the batch, the deviation form is filled & attached to the BMR along with the investigation Report.
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Release Certificates
The quality control analysis reports & release certificates are also attached to the BMR
Why Do We Need a BMR?
The simple answer to the above question is,
We Need BMR to full fill regulatory requirements & to check Product information like,
- Batch Number
- Batch Size
- Manufacturing Date
- Expiry Date
- Product Presentation
-
We need BMR to check which steps are to be used for manufacturing a specific batch.
- BMR is also required to check which equipment is to be used.
- BMR is required to check batch recipes including names & quantities of excipients & APIs.
After Manufacturing BMR is used for tracking the batch history. After batch manufacturing, it gives us information like,
- A batch manufacturing record is a very essential document & it provides us with the full history of batch manufacturing.
- We can trace out the personnel involved in the manufacturing of a specific batch.
- We can trace out which equipment was used during the manufacturing of a specific batch.
- We can trace out the qualified personnel involved in the manufacturing of a specific batch.
- We can verify which excipients’ lot numbers were used in a specific batch along with their quantities.
- We can verify which APIs’ lot was used for manufacturing.
- BMR gives us information about real-time or actual data at which the batch was granulated, compressed, coated,
- filled, or filtered.
- BMR also contains quality control reports & we can trace out the batch results.
Batch Manufacturing Record As an Investigation Tool
Unfortunately, if any batch is subjected to investigation due to any market complaint like the presence of foreign material in a unit of a specific batch then BMR & BPR (Batch packaging Record) is used to track its history from dispensing to dispatch.
As we discussed earlier all the information is fed in BMR during its manufacturing so we can easily trace out the excipients or APIs lots, source, etc. We can check & verify our QC test reports as well from the BMR.
Retention Period Of BMR
According to the GMP & FDA 21 CFR, the Batch Manufacturing Record must be retained for the period of Expiry Date + 1 year.
In simple words, BMR is retained in the record room for 01 extra year after the expiration of the shelf life of that batch.
Example
Suppose we manufactured a tablet batch & its manufacturing Date is March 2022 & Expiry Date is February 2024.
We will retain its BMR till January 2025 & after that, we can discard that BMR.
What is eBMR?
eBMR or EBMR is an electronic batch manufacturing record & it is electronically generated without using any paper.
So no paperwork or hard copy is required for eBMR, only we use different types of software to generate eBMRs which are filled online using real-time data.
Conclusion
A batch manufacturing record or BMR is a very important document & it contains all the manufacturing history of the batch so always put the real-time & actual data in the BMR during each step & don’t manipulate the data because the manipulated or fake data will create difficulties during the investigation of any batch if required.
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