The Best 20 GDP Practices Recording Data Original as per cGMP.

In this article, you will learn the best 20 Good Documentation Practice GDP recording data original 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 following considerations apply when recording original data according to cGMP Good Manufacturing Practices:

1. Record all handwritten entries at the time the event is performed.
2. An event with the name of the individual, who performed/observed, should be recorded to provide proof that it actually occurred. Data should be legible for the life of the document.
3. Use blue or black indelible, non-water soluble, and non-erasable ink (Pencils are not permitted).
4. Ditto marks ( ” ) or any other marks that imply “same as previous” are unacceptable.
5. Record data in every line/space/field, unless instructions on the form/medium/governing procedure allow for skipping those sections.
6. When permitted to be left blank, the line spaces or empty fields should be clearly identifiable with the statement “intentionally left blank”. Otherwise, unused line spaces or empty fields must be lined out as ‘N/A’ (Not Applicable), initialed, and dated.
7. Record data directly onto required forms/mediums or computer systems. When required form/medium is not used as the original record, retain the document containing the original data as the official record.
8. Pre-dating and post-dating of any entry is unacceptable.
9. When a form requires review or verification of any recorded data or activity conducted, the review or verification should be performed and signed by a person other than the one who recorded the data or conducted the activity.
10. Recorded data should be accurate, including the validity of the calculations.
11. Perform rounding and document significant figures as defined in the specific company procedures.
12. Include the unit of measure in recorded analytical data, as per established industry-standard nomenclature.
13. All documentation, including any attached reference, should be identified as the primary document.
14. Standardize abbreviations throughout the document for consistent interpretation. When using the abbreviation for the first time in the document, the definition should be included.
15. Ensure that the recorded date/time format used is consistent throughout a document, especially when signatures from multiple countries apply. Date format, e.g., mm-dd-yy or dd-mm-yy, should be used throughout the document.
16. Optionally, the date may be written with the month spelled (e.g., mmm-dd-yy, dd-mmm-yy, mmm-dd-yyyy, dd-mmm-yyyy, etc.). Time format should use a consistent designation as a 24-hour convention or as a.m./p.m., but not mixed.
17. The numeric value recorded should be legible.
18. The decimal number must be preceded with a zero (e.g. 0.05).
19. Commas in numbers should not be used since they can be mistaken as decimal points. (Note: This would not apply to documents in the French language as commas are the correct designation for numbers).
20. Pre-documented dates, such as those on calibration tags, cleaning records, or equipment logs do not need to be converted when transcribed onto a document.

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 Practices Recording 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.

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REFERENCES:

For more information about GDP Practices Recording 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 Practices Recording 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