Pharmaceutical industries are involved in the manufacturing of medicinal products which are finally utilized by the patients so a great level of care & compliance is required at each level of manufacturing.
What Is a Batch Manufacturing Record (BMR)?
1. A batch manufacturing record or BMR is a document that contains instructions on who a batch will be manufactured.
2. Also is the written instructions that must be followed step by step during the manufacturing of a batch.
3. Batch Manufacturing Record or BMR is a written document that contains the history of a specific batch of a product
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 which equipment & at which parameters.
How Batch Manufacturing Record or BMR Is Issued?
The quality assurance department has a master copy or master file of the BMR and prints the BMR after giving a specified Batch number to that batch.
Components of BMR
A Batch manufacturing Record or BMR consists of different components and can be divided into the following 2 main categories:
- Fixed Components
- Attachable Components
1. 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
- 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
- Batch Size
- Manufacturing Date
- Expiry Date
- BMR Revision Number
- Brief Product Description Including,
- Dosage Form
- Shape
- Dimension
- Color
- Storage Condition
- Shelf Life
2. The second portion of BMR contains the sheet where the names of all the personnel involved in various activities are mentioned with date & sign, all checklists and additional IPC sheets.
Equipment Cleaning & Deployment Sheet
The next part of BMR is the Equipment deployment sheet where the name of all the equipment is mentioned
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.
The pharmacist production in-charge signs every ingredient on the BOM sheet after verifying its quantity & code.
Critical Instructions
Before the start of manufacturing, any instructions can be mentioned in BMR related to materials or equipment handling.
Yield & Reconciliation
The yield is calculated after every major step.
Read also: cGMP Requirement for Pharmaceutical Manufacturing
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