The Best GDP Practices in Document Labeling & Pagination.

Best GDP Practices in Document Labeling & Pagination

 

In this article, you will learn the most recommended GDP Practices in Document Labeling & Pagination according to the Good Documentation Practices as per FDA requirements.   Moreover, you can discover how to get a Document Management and Control Procedure Template and Document Management Software Application to handle your training activities fast and easily.

The following example shows a document with a header and footer containing fields with information that describe a unique document number, revision date, page numbering, etc.

Document labeling and pagination -header and footer page
Document labeling and pagination -header and footer page

The Best GDP Practices in Data Labeling.

Make sure all documentation generated is identified and codified as per established labeling and numerical code identification for each type of documents.  Typically, each company uses its own logo and header to identify its cGMP documents and records.  For example, the following document contains document labeling and identification in the header section.

header example - Document labeling and pagination
Header Example – Document Labeling

 

Where supporting data/document is being used, label it with the document identifier of the test plan, qualification protocol, CAPA, Incident investigations, change request (CR), etc. Initial and date the attachment.

The Best GDP Practices in Document Pagination.

Pagination should be formatted as “Y of X”, where Y = the page number and X = total number of pages.  The page number can be placed in the header or in the footer section of each page.  For example, the following document showed the document pagination in the footer section.

 

footer example - Document labeling and pagination
Footer Example – Document Pagination

 

Attachments do not need to be included in the pagination of the parent document; however, each attachment should have its own pagination.

 

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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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Quality procedures templates

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 Good Documentation Practices GDP – Document Labeling & Pagination.

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 GOOD DOCUMENTATION PRACTICES GDP, CONTACT US (Hablamos Español)

REFERENCES:

For more information about Good Documentation Practices GDP – Document Labeling & Pagination, 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 – Good Documentation Practices GDP – Document Labeling & Pagination

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!