Page 16 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Labels and tags
Typical labels and tags used within the company
include cleaning tags and calibration tags.
These labels require (as a minimum) the date of the
operation and the signature or initials of the person
applying the label.
Logs and forms
Logs and forms, such as calibration or cleaning
records, document and provide evidence that
particular operations have been performed.
The information you are required to enter may be a
signature stating that the particular function has been
successfully completed, or it may be the recording of
a particular piece of information that is relevant to the
manufacture of a product.
Packaging
Packaging documentation provides evidence that the right products have been
packaged in the right container with right label, that is, the product is correctly
identified.
Personnel must ensure that the packaging instructions are followed exactly.
Packaging Bill of Materials and Master Packaging Instructions
Packaging batch records
Logs and forms
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