# 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 requirementsMoreover, 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
1. 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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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. now.

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## REFERENCES:

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.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

## 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!