Avoid the 7 Most Critical Errors & Mistakes in GDP Documentation.

Avoid the most critical mistakes in GDP Documentation


In this article, you will learn how to avoid serious mistakes in GDP documentation 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.

Here you can find a summary of the 7 Fatal Errors and Mistakes in GDP Good Documentation Practices.

In addition to the obvious errors and actions prohibited by the FDA as:

  • falsifying documents,
  • wilful reporting of false data,
  • misleading data,
  • writing using erasable ink or pencil;

Avoid the most dangerous errors during GDP documentation:

  1. Development information or creating results without performing the work.
  2. Backdating entries.
  3. Signing someone else’s name to a document.
  4. Filling in blanks without explanation. If handwritten data is left blank and filled in later, a signature, date, and an explanation must be included.
  5. Recording of data for work performed by another associate.
  6. Signing for work or for verification of work performed by another associate.
  7. Use and/or sharing of another person’s ID/password associated with electronic signatures.

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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 to prevent mistakes during GDP documentation.

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 and prevent mistakes during GDP Documentation on Good Documentation Practices  GDP, CONTACT US (Hablamos Español)


For more information about mistakes during GDP documentation in Good Documentation Practices GDP, refer to:













QS Regulation and Guidance • Quality System Regulation and Preamble – Mistakes During GDP Documentation in Good Documentation Practices GDP



Inspection Guide – Pages 8, 15, 21, 22 and 23


Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]


Picture of 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!