Page 15 - Documentation and Records
P. 15
GMP Training – Documentation and Records by www.gmpsop.com
PRODUCTION - TYPES OF DOCUMENTATION
Master formulas and processing instructions
The master manufacturing formula provides a
complete list of ingredients and their respective
quantities to be used in processing.
Master processing instructions describe exactly:
the way in which a product is to be manufactured
the sequence of processing
These instructions must contain enough information
to allow the company to re-create the manufacturing
operation exactly as it is supposed to occur.
Batch records
Batch records are properly authorized copies of the
master processing instructions.
They provide instructions of what to do and a record
of what was done, including a list of all materials and
components used and the quantities used.
Batch records provide evidence of the quality of our
products because operators are required to sign their
name to certify that the operations took place as
stated.
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