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GMP Training – Documentation and Records by www.gmpsop.com
Finished products
Specifications need to be approved by the Quantity Department, and are not to
be changed without their written approval.
TYPES OF SPECIFICATIONS
Starting materials
The requirements for starting materials must be well-
defined and documented to ensure that you get the
material you want, and that there are no mix-ups.
Starting materials are defined by:
A standard name
The supplier's code
A unique item code
A unique lot/batch number
Specifications for starting materials should include:
Inspections and/or tests required
Acceptance criteria
Storage conditions
A retest or expiry date
Packaging materials
The requirements for packaging materials must also
be well-defined and documented.
Packaging materials are defined by:
A standard name
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