How to Make GDP Corrections to cGMP Data in 10 Steps?

In this article, you will learn the 10 most common instructions to make Good Documentation Practices GDP corrections to cGMP Data as per FDA requirements.   Moreover, you can discover how to get a Document Management Procedure Template and Document Management Software Application to handle your training activities fast and easily.

The 10 Most Common Instructions to Make GDP Corrections to cGMP Information.

The following apply for changes or corrections to cGMP data:

1. The original entry should not be obliterated or obscured.
2. Write-over, correction fluid, or tape must not be used.
3. To ensure the original entry is legible after corrections are made, use a single line through the error. Cross through the entire data entry even if only a portion is incorrect.
4. Initial and date the cross through. If no space is available to record the correction, number the cross through.
5. Number and record the corresponding correction where space permits at the bottom or subsequent page. Initial and date the correction.
6. Initial and date all changes and comments. Insertions are considered corrections and should be initialed and dated.
7. Corrections can only be made by either the individual who recorded the data or that individual’s supervisor (or designated leader).
8. When a correction is to be made by the individual’s supervisor, an explanation for the correction should be provided with the signature and date.
9. Where the reason for correction is not evident, the reason for the change should be documented for each correction made.
10. Where space does not permit, clearly link each correction to the corresponding reason for the change at the bottom or subsequent page. Initial and date each reason.

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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Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on GDP corrections to cGMP data.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

Get in compliance today with GDP corrections to cGMP data, CONTACT US (Hablamos Español)

REFERENCES:

For more information about GDP corrections to cGMP data, 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 – GDP corrections to cGMP data

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