The Best Practices in Document Retention Time as per GDP.

how to establish the document retention time as per GDP 2

 

In this article, you will learn how to establish the document retention time as per GDP Good Documentation Practices and FDA requirements.

The following table shows the minimum document retention time recommended for each GMP type of document:

Type of Documents Minimum Retention Period
Batch related Records (Executed Documents & Analytical Report- Chemical & Microbiology) 1 year beyond the expiry date whichever is longer.
Legal Documents (Mfg. Lic., Regulatory Approvals, Certificates) for Posterity
Master Documents / Supersedes / Obsolete Copy of Master Document
SOP (Standard Operating Procedures) 5 years from the Obsolete Date
Standard Test Procedures (STP), 5 years from the Obsolete Date
Site Master File

Master Formula Card & QFR, BMR& BPR

For Posterity (Current version)

5 years from the obsolete Date

Stability Study Protocol & Reports For Posterity

For more information questions and answers about Good Documentation Practices GDP and Compliance With Drug CGMP Guidance for Industry press here.

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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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GET IN COMPLIANCE TODAY ON HOW TO DOCUMENT RETENTION TIME ACCORDING TO GOOD DOCUMENTATION PRACTICES GDP, CONTACT US (Hablamos Español)

REFERENCES:

For more information about document retention time as per Good Documentation Practices GDP, refer to:

https://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

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

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

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

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

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

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

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

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

QS Regulation and Guidance • Quality System Regulation and Preamble – document retention time 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

https://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

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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