BATCH RECORD REVIEW/ RELEASE BY EXCEPTION – PDF Download

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Batch Record Requirements EU

Chapter 4.20 A Batch Processing Record should be kept for each batch processed. It
should be based on the relevant parts of the currently approved Manufacturing Formula
and Processing Instructions, and should contain the following information:

a) The name and batch number of the product;

b) Dates and times of commencement, of significant intermediate stages and of
completion of production;

c) Identification (initials) of the operator(s) who performed each significant step of the
process and, where appropriate, the name of any person who checked these
operations;

d) The batch number and/or analytical control number as well as the quantities of each
starting material actually weighed (including the batch number and amount of any
recovered or reprocessed material added);

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