Page 21 - Documentation and Records
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GMP Training – Documentation and Records by www.gmpsop.com
Complaint investigation is a critical activity to protect patients' health. If the
records are not accurate and complete, incorrect conclusions may be made
about the problem.
They are used to investigate trends or problems.
Often, production or product history need to be checked for trends. This can
only be done if the records are accurate and complete.
They are always reviewed during government audits.
Auditors review records to ensure they are accurate and complete and follow
GMP. They place importance on this review when forming opinions on
company GMP standards.
Completing records
Here are some simple rules for completing records:
Records must be accurate.
Records must be completed in real-time.
Records must be legible.
Records must be completed in a non water-soluble pen.
Records must be stored to prevent loss or destruction.
Never use whiteout or erasers.
To correct data, cross out the incorrect data with one line, enter the new
information, sign or initial it, and date it.
Fill in all fields, even if you write "Not Applicable".
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