Our Database comprehends mainly Master Batch Records. If such a MBR is printed or downloaded it can be modified and amended with the necessary processing information for one batch (=Batch Record).
Please find an example of an Batch Record and the most used key sections. The colours should help finding the orientation in the Batch Record sheet and the explanations support the understanding of their function.
Batch Record / Batch Processing Record
A batch processing record should be kept for each batch processed. During processing, the following information should be recorded at the time each action is taken, and after completing the record should be dated and signed by the person responsible for the processing operations.
A Master Batch Record (MBR) or also called Master Formula (MF) is required for each batch and batch size. A „batch“ as defined in the WHO GMP guideline (TRS 908 Annex 4) is„batch (or lot)
A defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produces in a fixed time interval.”
“Master Batch Record/ Master formula
A document or set of documents specifying the starting materials with their quantities and the packaging materials, together with a description of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions, including the in-process controls.”