If it is not written down, it did not happen – Complying with FDA’s Good Documentation Practices

Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from “good distribution practice” also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety. Documentation provides both:

  • Information on when, where, who, why and how to complete tasks, and
  • Evidence proving that the tasks have been completed as they should be.

If an instruction or record is poorly documented, then the manufacture or Quality assurance/control of a product as well as patient safety can be negatively impacted. The standard of documentation within a company can directly impact the level of success in quality of products that are safe as well as success during audit situations. Consequently, GMP / GLP / GCP regulations from PIC/S, FDA, ICH and EU all include mandatory sections on documentation.

Why You Should Attend:

As the FDA and TGA say “If it isn’t written down, then it didn’t happen”

To meet industry standards, it is critical that all documentation follows GDP when it affects:

  • GMP / GLP / GCP processes
  • Material or product identity, quality, purity, strength and safety
  • The validated state of GMP / GLP / GCP product manufacture, facilities, equipment, computer systems and testing methods.

It is recommended that your company has a policy or procedure outlining the expected GDocP standards, particularly for those requirements that may be unique to your company – for example, using a specific pen color or when and how to use scanned documents/records as original data.

Areas Covered in the Session :

  • Basics of Good Documentation Practices
  • Documents vs records
  • How to write or record information in a compliant way (includes text, numbers, electronic signatures etc)
  • How to amend documents or records in a compliant way
  • Specific contents will include but are not limited to:
    • Document Creation
    • Document Approval
    • Handwritten Entries
    • Copies of Documents
    • Document Maintenance
    • Document Modification
    • Warning Letters for GDocP

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • IT and Software Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Validation Departments
  • Marketing Departments
  • Documentation Departments
  • Laboratory Professionals
  • Clinical Research Associates
  • GXP Professionals
  • Everyone that creates records in a regulated industry


Angela Bazigos

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences.



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