Page 5 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Manufacturing documents should clearly define the manufacturing process, be
easy to use, and be easy to check. They should provide a complete history of all
batches manufactured.
There are rules as to how GMP-compliant documents and records are handled:
Standard Operating Procedures (SOPs) and Work Instructions (WIs) must be
kept current and must be readily available at the worksite.
All SOPs, WIs and batch processing instructions must be followed exactly.
Any deviations from procedures should be reported to supervisors.
Batch documents must be verified and approved before issue to
manufacturing.
It is the responsibility of management to provide a documentation system that
conforms to the GMP requirements, and then train the users in the requirements
of the system.
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