Page 27 - Documentation and Records

GMP Training – Documentation and Records by www.gmpsop.com

Directions for handling atypical occurrences within the system.

Documentation may consist of logbooks, worksheets, electronic data, highly
controlled paper documents, equipment readout or charts.

Revision of documents

GMP document revisions should be properly controlled through a formal revision
system as part of the document management system. Documents should be
approved, signed and dated by appropriate and authorized persons, as defined
in procedures approved by Quality Assurance. As part of the document
management system there should be a method in place to assure that GMP
documents are revised regularly to comply with the GMP requirement that states
that all documents should be complete and accurate. When revised documents
are issued, there should be a method in place to promptly remove superseded

revisions from the area. Only official records and procedures should be used by
personnel.

If approved documents (e.g., validation reports, released batch records, etc.) need
to be amended, only appropriate personnel who have proper authorization may
amend the documents. There should be a system in place to manage proposed
amendments to approved documents.

Retention of documents

The site should have a record retention schedule for different types of
documents. All records associated with a manufacturing lot should be retained
for a minimum of one year after the drug product expiration date. Validation
records or other records that are not specific to batches or lots may have to be

retained longer.

Records may be retained as original copies or true copies, e.g. microfilm, scanned
copies, etc. Documents may be stored off site but must be easily retrievable.
Original raw data of manufacturing and the laboratory should be retained
according to site procedures.

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