All cGMP manufacturers are required to keep separate Master Batch Records (MBRs) and Batch Production Records (BPRs) in order to comply with FDA regulations.
Master Batch Records, also known as Master Manufacturing Formulas, are general manufacturing instructions. Each unique formulation and batch size must have its own MBR and should include:
- Identification of product name
- Bill of Materials detailing the Weight, measure or count of each component needed to manufacture the batch.
- Equipment list.
- Component list.
- Statement of theoretical yield at each step in the manufacturing process.
- Expected yield of the finished product.
- Specific instructions for each state in the manufacturing process.
- Sampling and testing procedures.
- Instructions for manual operations.
The purpose of an MBR is to ensure that all proper ingredients are added and that each step in the process is completed.
Batch Production Records are copies the Master Batch Record. The BPR record documents when, how, by whom, with what tools and in what environment a product was produced. The Batch Record is where operators record specific lot numbers as well as the specific weights, measure or count of ingredients and components actually used to produce that specific batch.
Whereas the Master Record serves as a template for the manufacturing process, the purpose of a BPR is to show that each specific batch of product was created in accordance to the MBR and also explain all deviations that may have occurred during production of any given batch. The Batch Record serves as a controlled record of the process in order to maintain traceability of raw ingredients and manufacturing practices.