Automation is everywhere in everything whether we can see it or not. From individuals to industries, it has transformed everything. Especially in Pharma manufacturing where the electronic batch manufacturing record (eBMR) is important and mandatory. Automation has transformed the eBMR in pharma like a boon.
1.) Weighing & Dispensing data pull
Previously weight of the raw material that was going to be processed was manually entered into the eBMR in pharma. Then it is dispensed manually in bags as per the required quantities.
Now the eBMR in pharma can automatically pull the data from the weight machine and auto-alert the user if the weight exceeds the limit. It also auto-distributes the material reducing the working burden.
2.) IPQC Automation
In-process quality Control (IPQC) is crucial in the pharmaceutical industry for quality maintenance throughout the process. It involves all Inspection of raw material, equipment, environment, process, and testing concerning specification, packing, and so on. This is very crucial and takes time and effort to enter manually.
Now with the help of automation, the crucial data of every single process is auto-updated on eBMR in pharma. That generates an on-time errorless batch record.
3.) MBR Creation & Verification
Master Batch Record (MBR) is like a recipe book where you find the perfect recipes.
The eBMR in pharma automatically creates MBR that contains the instructions, recipe or formula, and specific manufacturing process for a particular product. This helps in further production by using the right ingredients and the right processes in the right order to make the product as it is designed. It also provides the scope to explore new recipes with the help of MBR. The eBMR also auto-verifies whether the output is perfect or not.
4.) Stage & Material Verification with Traceability
Manufacturing in a manual process creates labels in each stage for material verification which takes more time and can create dilemmas for the final level of verification.
Automation has solved the dilemma with one single level which will automatically update your system in each process the material passes. It verifies the material status from the updated level till the final process.
5.) Compliance
In pharmaceutical manufacturing compliance is mandatory.
The eBMR in pharma records the data in such a way that it meets such compliances. Fine software like ProcessXE® by Sarjen Systems meets 21 CFR Part 11, Annex 11, ALCOA(+), GAMP 5, cGxP compliances and simplifies the bother of regulations.