Good documentation practice

Good Documentation Practice (commonly abbreviated as GDP, GoodDoc or GDocP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDP / GDocP standards are codified by various agencies such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), others are not but represent the industry's best practice.

Overview

Good Documentation Practice is a key part of the quality assurance systems. It is an essential part of the quality systems as per the Good Manufacturing Practice (GMP) regulations. The GDP regulations provide a framework for the systematic management and control of documentation throughout all stages of the product lifecycle.

Importance

Good Documentation Practice is crucial in the medical and pharmaceutical industries. It ensures that all documentation is systematically managed and controlled. This is important for several reasons:

• Traceability: Good documentation allows for the traceability of all activities performed including the handling of any deviations or changes made to the process. This is important for both internal and external audits.
• Accountability: It ensures that all activities can be traced back to the person performing them, thus ensuring accountability.
• Reproducibility: Good documentation ensures that processes can be reproduced consistently over time, which is crucial in the pharmaceutical industry where consistency is key.

Principles

The principles of Good Documentation Practice include:

• Accuracy: All documentation should be accurate, and reflect exactly what was done.
• Timeliness: Entries should be made as soon as possible after the task is completed. Delays can lead to errors or omissions.
• Completeness: All documentation should be complete, with no blank spaces or missing entries.
• Consistency: The style and format of documentation should be consistent throughout.
• Endorsement: All entries should be signed or initialed by the person making the entry, and where necessary, countersigned by a witness.

See also

• Good Manufacturing Practice
• Quality Assurance
• Food and Drug Administration
• European Medicines Agency