8 Questions
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.
True
Original information refers to data, including signatures and dates, and can exist only in hard-copy form.
False
The SOP No. for Good Documentation Practice is SOP/QAD/001-01.
False
Legible information means that the data can be read easily.
True
Approved documents are pre-prepared data entry documents approved for recording original information, such as production records and logbooks.
True
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
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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