Page 8 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Version number
Date of introduction
Date of review (or expiry)
Signatures of at least the qualify unit and the author or subject matter expert
A reference to previous document history
Introducing a standard procedure
All procedures that may impact product quality, that is, those procedures that
would be governed by GMP, must be introduced in a formal manner.
GMP rules on introducing a procedure include:
Procedures must have an official introduction or "Effective on:" date.
Procedures must be authorized or approved.
Procedures must be accompanied by a documented training event for all
users. The resulting training record must be available.
Procedures must be located such that they are directly available to the users.
Completed batch records must accurately reflect what actually happened during
manufacture and packaging.
Once the product leaves the warehouse, only the batch and test records remain
as evidence of good manufacturing practice. If there is an error in the record,
particularly if it relates to a formulation, should be formally investigated as soon
as possible.
Waiting to see if the GMP auditors find it misses the point, as it may delay
recovery or correction of a significant safety problem.
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