Title: Good Documentation Practices
Course: BTEC-1300-301-302-303-F21 > Section: Document Controls and Document Types

Good Documentation Practices (GDP) are standards by which documents are created and maintained in a regulated environment, including STUDENTfacturED. They are an essential part of document controls. GDPs maintain accuracy, clarity, and traceability in documents and products. GDPs need to be followed by everyone who documents activities, including biotechnicians filling out forms.

Some good documentation practices are codified by various regulatory authorities. Other GDPs aren’t codified by any regulating bodies, but are considered part of current good manufacturing practices.

There is no code of federal regulation specifically covering good documentation practices. However, one of the most common findings during FDA inspections is lack of reliable, accurate, and adequate documentation.

Learning Objectives:

- 2.4 - Complete appropriate documentation using good documentation practices contemporaneously to making a product.