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.
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. Discover how a well-designed EBR solution can help you overcome the main challenges of the Pharma Industry.
Manufacturing Execution Systems (MES) is a specialist class of production-oriented software that manages, monitors, and synchronizes the execution of real-time, physical processes involved in transforming raw materials into intermediate and/or finished goods. These systems coordinate this execution of work orders with production scheduling and enterprise-level systems like ERP and product life cycle management (PLM)