Page 17 - Documentation and Records
P. 17
GMP Training – Documentation and Records by www.gmpsop.com
PRODUCTION - TYPES OF DOCUMENTATION
Packaging Bill of Materials and Master
Packaging Instructions
The Packaging Bill of Materials and Master Packaging
Instructions contain all the specific information
required for labeling a product. These instructions
should also include areas for calculating final yield,
and for calculating the reconciliation of packaging
items.
Packaging batch records
Packaging batch records are properly authorized
copies of the master packaging instructions.
Packaging batch records provide instructions of what
to do and are accurate records of what was actually
done. They include a list of all materials and
components used and the quantities used.
Packaging batch records provide evidence of the
product quality because operators are required to sign
their name to certify that the operations took place as
stated.
Packaging batch records provide evidence of correct
product identity. Operators are required to sign their
name to certify that the operations took place in line
with approved instructions, and the current revisions
of the printed matter were used in the packaging
operation.
It is standard practice to apply one certified sample of
each item of printed matter used in the packaging as
part of the packaging batch record.
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