Good Documentation Practice (GDP)

 Good Documentation Practice (GDP) is a set of guidelines and best practices that ensure that all documents related to the manufacture, testing, and distribution of pharmaceuticals, medical devices, and other healthcare products are complete, accurate, and reliable. GDP guidelines cover all aspects of document management, including creation, revision, review, and retention.

The key principles of GDP include:

  1. Traceability: All documents should be uniquely identified, dated, and signed to enable traceability throughout the product life cycle.

  2. Accuracy: All documents should accurately reflect the activities performed and the data collected, with no falsification, alteration, or omission of data.

  3. Completeness: All documents should be complete, with no missing pages, blanks, or gaps in the data.

  4. Legibility: All documents should be legible, with no handwriting, abbreviations, or codes that cannot be understood by others.

  5. Timeliness: All documents should be completed in a timely manner, with no undue delay in recording or reporting data.

  6. Security: All documents should be protected from loss, damage, or unauthorized access or disclosure.

  7. Retention: All documents should be retained for the required period, as specified in the relevant regulations or company policies.

Adherence to GDP guidelines is essential for ensuring the quality, safety, and efficacy of healthcare products, as well as for compliance with regulatory requirements. Failure to comply with GDP guidelines can result in regulatory actions, such as product recalls or sanctions, or damage to the company's reputation.

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