Most pharmaceutical manufacturing companies have understood that in order to achieve the stated goal of long-term business survival in today’s regulated environment, they need to install a full eMES also called the eBMR system. However, the current infrastructure situation prevents such implementation from proceeding ahead. Before the discussion between BMR And eBMR first, read the difference between BMR/BPR.
However, Pharma companies work in one of the most dynamic and regulated industries in the world. The frequency of regulatory audits has grown. The number of warning letters and import restrictions has also increased. Many businesses fail to pass regulatory audits. Failed to pass an audit results in a two-year loss of revenue and significant costs for re-audit success.
Difference between BMR And EBMR/EBPR
BMR: A batch manufacturing record is a written document that is used to record the entire manufacturing process and history of that product or any products. in other words, it tells you how to manufacture a product or batch and records the way that happens.
BPR/BPCR: Batch packing record is a written document of the batch starting from dispensing to the end of dispatch stage, which tells about the procedure and stepwise instructions to be followed during the packing of each batch.
eBMR: eBMR is an electronic batch manufacturing record, the modules are a web-based solution that ultimate the manufacturing process from dispensing of raw material to manufacturing and packaging, which is very helpful in the capture of data in different operations.
Software for eBMR/eBPR:
- Atachi system
- Serjen system
- Laurus MES software
Advantage of eBMR in Pharmaceuticals
- eBMR shall comply with 21CFRPart11 of FDA and Annexure 11 of EU
- Users shall be able to do manual entry in the centralized application by which we shall get data, users, workflow, report, and status.
- To provide application-based reading and writing provision and controls in order to avoid recording errors.
- To meet documentation requirements as per ALCOA+
- To Facilitate faster getting or retrieval of historical data.
- Minimization of paper uses.
- To capture real data and real-time by the right person in batch process control record.
- BMR And eBMR both enforces compliance, but eBMR minimizes the review cycle time, hence also decreasing the manufacturing cost.
- It helps in the process and product tracking.
- Improve the visibility of the manufacturing process.