Page 19 - Documentation and Records

GMP Training – Documentation and Records by www.gmpsop.com

Test methods contain, or reference, all the information
needed to test materials and products.

Test records

Test records are documents that provide accurate
evidence of the quality of products. As such, they are
very important legal documents.

The record for a test must contain all testing data,
dates and signatures. It must also identify the test

method and must allow all calculations to be checked.

The method of recording should allow for reviews of
past results and the detection of trends.

Master processing instructions are probably the most critical documents in the
plant. They provide the official registered, validated, company-approved
instructions, and as such ensure product safety and compliance. Failure to
follow the current instructions could lead to defective product, possible recalls,
and harm to patients. Product manufactured not in compliance with the

government-resisted details is against the law.

It is never permissible to hold unofficial photocopies of master instructions for
convenience. One only approved copy of the current, approved master
instruction should be released each time a batch is to be prepared, because from
time to time these instructions are updated to a new version.

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