How to Write a Memorandum in Compliance with GDP.

In this article, you will learn how to write a memorandum in compliance with GDP Good Documentation Practices 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 7 Best Good Documentation Practices GDP of Memorandum.

Memorandum is the use of a memorandum or letter to document, support, or explain a record.

The following best practices apply for memorandum:

1. When provided as supporting evidence to a quality record, a memorandum should be signed and dated by the author.
2. Where a memorandum is provided to a project or investigation, it should bear a cross-reference to the corresponding activity file number such as report number, incident investigations, CAPA, Non-conformance, Audit observation number, etc.
3. The use of e-mails as quality records should be limited and only occur where no other applicable records are available.
4. If an e-mail is used as a quality record, the email content shall be limited to the immediate subject, with no additional attachments or subjectivity/personal opinions.
5. The e-mail shall include the corresponding activity file number as detailed above.
6. If the record is to be maintained as a hard copy, the e-mail shall be printed and the author or recipient shall sign and date the e-mail.
7. If the record is to be maintained as an electronic copy, the e-mail shall be printed, signed, and dated by the author or recipient and then converted to a non-editable file format.

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 memorandum in compliance with GDP Good Documentation Practices.

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 MEMORANDUM IN COMPLIANCE WITH GDP GOOD DOCUMENTATION PRACTICES, CONTACT US (Hablamos Español)

REFERENCES:

For more information about how to write a memorandum in compliance with GDP Good Documentation Practices, 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 – memorandum in compliance with GDP Good Documentation Practices

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