If it Isn't Written Down, then it Didn't Happen: Complying with FDA's Good Documentation Practices

Overview:

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 Will Benefit:

• Anyone that creates records in a regulated industry including Laboratory, Clinical and Manufacturing Staff, as well as IT /Software Staff