Page 4 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Manufacturing
Quality control testing
Finished product distribution
Incidents and devotions
Complaints
Documentation allows an investigation, if required, into the manufacture of the
batch. It also allows traceability to where the products were sent.
GMP compliant documents
A compliant documentation system should:
have written procedures that are well-defined, understood and
prevent misinterpretation and error
be unambiguous
have accurate records that provide evidence of performance
allow calculations to be checked
allow tracing of a batch history, in some situations, over months or years
Batch records must be stored safely, and must be able to be relieved when
necessary.
GMP documentation and records
Records are the documented history of the manufacturing process. They must
be complete and accurate, and demonstrate that authorized procedures were
followed (if it's not documented, it wasn't done).
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