Good Documentation Practices

Good Documentation Practices (GDP) in the pharmaceutical industry are essential for ensuring product quality, safety, and efficacy. GDPs encompass a set of guidelines and principles for creating, reviewing, approving, distributing, and maintaining documentation throughout the product lifecycle.

Key principles of GDP include:

• Legibility: Documents should be clear, concise, and easily readable.

  Traceability: Documents should contain sufficient information to track their origin and any changes made.

  Accuracy: All recorded data should be true and accurate.

• Completeness: Documents should provide a comprehensive record of activities, including any deviations or unexpected events.

  Timeliness: Documents should be created and reviewed promptly.

• Originality: Documents should be the original record of information, not a copy.

Adherence to GDPs helps maintain regulatory compliance, facilitates efficient operations, and supports effective decision-making within the pharmaceutical industry.