Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records (PBR), also called master production batch records (MPBR), for FDA-compliance purposes.
With the advent of 21 CFR Part 11 in 1997, the FDA began to accept electronic batch records systems. Since then, more and more manufacturers have recognized the advantages of automating the process of controlling batch records.
Under CGMP regulations found in 21 CFR Parts 210-211, the electronic batch record (EBR) must demonstrate the accomplishment of every significant step in the production, packing, and holding of each batch of a drug product.
GCP requires extensive EBR System documentation, including batch dates, the identity of major equipment/lines used, components/materials used and their weights, in-process and laboratory control results, complete labeling control records, sampling, and identification of personnel supervising or checking each step.
Ensure compliance and improve efficiency by automating your paper-based systems. The right electronic batch record (EBR) software system removes the documentation burden from quality and manufacturing teams. … It also improves product quality and key performance metrics.
Making sure each manufacturing batch record meets regulatory requirements is a challenging task. This is because in today’s pharmaceutical manufacturing environment, production runs are shorter, product complexity is increasing and quality expectations are greater.