A batch manufacturing record (BMR) is a key document for every manufacturer, where quality is the top concern. It contains every detail of materials used, processes followed, types of equipment involved, and proper authentication of persons responsible for each activity in the entire process for a particular batch.
What is an electronic batch manufacturing record (eBMR)?
it is the electronic/digital form of the BMR. In industries like pharmaceuticals where the documentation process is very complex; it’s almost impossible to create BMR with all the regulatory compliances. So here eBMR software in pharma plays a crucial role that helps create such records easily with all the compliances.
What information should be added to a batch manufacturing record?
While the Master Formula Record specifies how to manufacture a standard size or percentage of material, the BMR records how these instructions are carried out. This needs scaling the Master Formula Record (MFR) to meet the required amounts.
Every batch manufacturing record must include all the information related to generating the product batch, including-
- Determine manufacturing process start and completion dates.
- Document all materials and components utilized, including quantities.
- Provide step-by-step documentation of the manufacturing process, including completion dates.
- Initials of the person executing and confirming each step, with dual signoffs if needed.
- Provide health and safety information for each production phase, including possible dangers and PPE requirements.
- Lists of equipment and processing lines utilized.
- Results of quality control tests (QCT) and rank checks, including deviations from process and results/co-products.
- Provide maintenance and cleaning information for equipment and processing lines, including date and time performed, health and safety information, and mandatory PPE.
- Compare actual and predicted batch yields.
- Requirements for packaging and labeling, including documentation.
- Provide a bill of materials and the bill number.
- Provide definitions for any acronyms used.
- Maintain a change record and audit trail.
- List batch, lot, and control numbers for packed, labeled, and distributed completed products.
- Proof that the completed product fulfills defined requirements.
Benefits of batch manufacturing records software
Batch manufacturing record software makes filling out those long and complicated forms much easier.
- Saves time and reduces errors – No more handwriting or messy spreadsheets.
- Ensures you follow the rules – Ensure quality compliance by meeting quality and safety regulations.
- Makes everything run smoother – Connects your batch records to other parts of your business, like inventory and sales.
EBMR software in pharma benefits by integrating with ERP systems-
Faster production– Get things done quicker by preparing materials in advance and streamlining approvals.
Everyone on the same page- Connects your data across departments so everyone has the latest info.
Less rework, less waste- Automates tasks and reduces errors for better quality and less wasted materials.
Real-time updates- Ensures everyone has the most recent info on materials, formulas, and inventory.
Smarter decisions- Gives you better insights into your production process to make informed choices.
Easier reports- Built-in tools generate reports on a single click.
Plays by the rules- Helps you follow regulations to avoid fines and keep everyone safe.
Craft eBMR with us while fulfilling all these criteria with all the compliance.
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