Podcast
Questions and Answers
The SOP for Good Documentation Practice has an effective date of 25-03-2020.
The SOP for Good Documentation Practice has an effective date of 25-03-2020.
True (A)
The next review date for this SOP is 24-03-2023.
The next review date for this SOP is 24-03-2023.
False (B)
Reports are described as an assembly of facts, data, and opinions about a topic.
Reports are described as an assembly of facts, data, and opinions about a topic.
True (A)
All GMP documents must be maintained in accordance with the written procedures that define format filling, archive & security.
All GMP documents must be maintained in accordance with the written procedures that define format filling, archive & security.
Original information refers to data, including signatures and dates, and can exist only in hard-copy form.
Original information refers to data, including signatures and dates, and can exist only in hard-copy form.
The SOP No. for Good Documentation Practice is SOP/QAD/001-01.
The SOP No. for Good Documentation Practice is SOP/QAD/001-01.
Legible information means that the data can be read easily.
Legible information means that the data can be read easily.
Approved documents are pre-prepared data entry documents approved for recording original information, such as production records and logbooks.
Approved documents are pre-prepared data entry documents approved for recording original information, such as production records and logbooks.
Flashcards
Effective date of GDP SOP
Effective date of GDP SOP
The SOP for Good Documentation Practice was put into effect on this date.
Maintenance of GMP documents
Maintenance of GMP documents
Documents that define format filling, archiving, and security.
Legible information
Legible information
Data that can be easily and accurately read.
What are reports?
What are reports?
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What are approved documents?
What are approved documents?
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Original Information
Original Information
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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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