Method

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).
For better understanding as a first time reader/user please read the explanations carefully.

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.

 Vocabulary/ Definitions

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.”
“Batch Record
All documents associated with the manufacture of a batch of bulk product of finished product. They provide a history of each batch of product an of all circumstances pertinent to the quality of the final product.”

Batch Record versus Master Formula/Master Batch Record

In the regulations and guidelines there are also requirements for completed batch records. The Master Batch Record (MBR) or Master Formula (MF) is essentially the blank batch record for the production operations (blank spaces are provided for the entry of data as the production run progresses). The batch processing record (BPR) is the approved copy of the master document with filled data entries, signatures dates, operators, lot numbers, records of equipment and more. Therefore the batch record BR often called Batch Processing Record BPR is the MBR/MF with all data entered plus all results of the supporting operations (in-process test results, environmental monitoring, autoclave records, etc.
Source: WHO GMP guideline, WHO Guide to Master Formulae