Good Documentation Practices
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Questions and Answers

The SOP for Good Documentation Practice has an effective date of 25-03-2020.

True

The next review date for this SOP is 24-03-2023.

False

Reports are described as an assembly of facts, data, and opinions about a topic.

True

All GMP documents must be maintained in accordance with the written procedures that define format filling, archive & security.

<p>True</p> Signup and view all the answers

Original information refers to data, including signatures and dates, and can exist only in hard-copy form.

<p>False</p> Signup and view all the answers

The SOP No. for Good Documentation Practice is SOP/QAD/001-01.

<p>False</p> Signup and view all the answers

Legible information means that the data can be read easily.

<p>True</p> Signup and view all the answers

Approved documents are pre-prepared data entry documents approved for recording original information, such as production records and logbooks.

<p>True</p> Signup and view all the answers

Study Notes

Good Documentation Practice

Records

  • Contain data obtained for a specific task (e.g., validation data) and are authenticated by dated signatures
  • Provide a history of each batch of product

Reports

  • Are a compilation of facts, data, and opinions about a topic (e.g., audit reports)

Legibility and Clarity

  • Information/data should be easily readable (legible)
  • Information/data should be easily understood and free from ambiguity (clear)

Approved Documents

  • Are pre-prepared data-entry documents approved for recording original information
  • Examples include: production records, data entry forms, logbooks, laboratory records, etc.

Original Information

  • Refers to data, including signatures and dates, that documents an activity and exists in any form (hard-copy or electronic file)

General Document Requirements

  • All GMP documents must be maintained according to written procedures that define:
    • The revision, review, approval, and issuance/distribution process
    • Required technical/review and approvals
    • Format filling, archiving, and security
    • Retention period

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Description

This quiz covers the importance of good documentation practices, including records, reports, and legibility and clarity in documentation. Learn about approved documents and more.

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