The 3 Habits for Handling Lost Documents as per GDP.

In this article, you will learn the top 3 practices handling lost documents as per Good Documentation Practices GDP.  Moreover, you can discover how to get a Document Management and Control Procedure Template and Document Management Software Application to handle your training activities fast and easily.

The Best 3 GDP Practices for Handling Lost Documents.

1. What to do if you have an available copy of a lost document?

• Document and explain why a copy of the document is being used instead of the original, and include signature and date.
• If the original document is found after the use of a copy, retain the copy and attach it to the original. Write a comment specifying the date when the original document was found, then sign and date the comment. If no additional new information or data is recorded on the copy or if the document is still open when the original is found, retain the original copy and then the copy can be scrapped.
• The respective management representative, manager, supervisor, or team leader designees, shall approve the document(s).

2. What to do if you have a lost document with recoverable information from an official document?

• Document and explain the reason why recoverable information or data is being used instead of the original.
• Sign and Date the comment.
• Make reference or copy to applicable document or data source.
• The respective management representative, manager, supervisor, or team leader designees, shall approve the document(s).

3. What to do if you have a lost attachment document?

• Documents such as protocols, investigations reports, and/or final reports used as attachments shall be searched in the document management system to get a copy of the attached document.
• Attachments must be page numbered.
• Attachment must be a reference to the applicable record number.

For more information, questions, and answers about Handling Lost Documents as per Good Documentation Practices GDP and Compliance With Drug CGMP Guidance for Industry press here.

CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES:

For more information about Handling Lost Documents as per Good Documentation Practices GDP, refer to:

httpss://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-Good-Manufacturing-Practice-Guidance-for-Industry.pdf

TITLE 21–FOOD AND DRUGS

SUBCHAPTER A–GENERAL

PART 11  ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

httpss://clarkstonconsulting.com/insights/guidance-data-integrity/

https://www.climet.com/data-integrity/

https://www.biopharminternational.com/data-integrity-electronic-records-according-21-cfr-part-11

httpss://www.pda.org/docs/default-source/website-document-library/chapters/presentations/missouri-valley/data-integrity-issues-concernse703e9d7a8c4657391feff0000cd242a.pdf?sfvrsn=4

httpss://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

httpss://www.fda.gov/media/118202/download

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble – Handling Lost Documents as per Good Documentation Practices GDP

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

httpss://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm