Page 18 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
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.
Quality Control (QC)
QC records provide evidence of the quality of materials and products.
Testing must be performed in accordance with methods described, or referenced,
in specifications.
Results of all testing are recorded and retained as part of the batch records.
Test methods
Test records
QUALITY CONTROL - TYPES OF DOCUMENTATION
Test methods
Samples of starting materials, in-process goods and
finished products are taken in accordance with
written sampling plans and procedures.
Testing is performed in accordance with the methods
described or referenced in specifications.
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