Top 6 Numerical Rounding Instructions for Results and Calculations cGMP.

In this article, you will learn the 6 basic numerical rounding instructions of results and calculations related to Good Documentation Practices GDP and current Good Manufacturing Practices cGMP 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.

1. Where the calculation/result is measured against a specification, the measurement must be reported to the same number of decimal places as the specification.
2. If the value of the number after the specified number of decimal places is less than 5, the number to be reported is rounded down.
3. If the value of the number after the specified number of decimal places is greater than 5, the number to be reported is rounded up.
4. If the value of the number after the specified number of decimal places is equal to 5, the number to be reported is rounded up.
5. If by rounding the number up or down the final digit is 0 (zero) then report this in the result.

       Examples are as follows:

• 196935 rounded to 5 decimal places is 75.19694
• rounded to 4 decimal places is 1969
• rounded to 3 decimal places is 197
• rounded to 2 decimal places is 20
• rounded to 1 decimal place is 2
• rounded to the nearest whole number is 75

6. Where no such specification is available, data will be rounded to the nearest whole number, or to a maximum of two decimal places, where applicable.

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 Numerical Rounding Instructions on 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 – Numerical Rounding Instructions on 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