Follow
Batch Processing Record – A batch processing record should be maintained 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 Product name and batch number.
b. Date and time of commencement, significant intermediate stages and completion of production.
c. Identification of the operator who performed each critical step of the process and, where appropriate, the name of any person who checked these operations.
d Batch number and analytical control number as well as the amount of each starting material actually weighed.
e A record of the controls in progress and the initials of the person(s) carrying them out and the results obtained.
f yield of products obtained at different and relevant stages of production.
g Notes on special issues with details including signed approval for any deviations from manufacturing formula and processing instructions.
h. Authorization by the person responsible for the processing operations.
