Page 14 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
"Reject" labels should be used only for materials that
are unfit for use. Those of uncertain status or destined
for recovery, re-processing and the like should be
designated "Held" or "Quarantine".
Standard Operating Procedures (SOPs) and Work
Instructions (WIs)
SOPs and WIs are documents that describe how to
perform a particular operation or task.
They must be readily available at the worksite.
You must understand them and follow them exactly
for all duties you are trained to perform.
Production
Production documents provide evidence of the processing and quality of
products.
All personnel must understand the importance of these documents.
Manufacturing instructions must be followed exactly, and batch records must
be accurate, be complete, and recorded in real-time.
Master formula and processing instructions
Batch records
Labels and tags
Logs and forms
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