Good Documentation Practices
This is the only writing tool allowed when completing GxP records.
What is a "blue or black ink pen"?
This document provides step-by-step instructions to ensure consistency and compliance in performing tasks.
What is a "Standard Operating Procedure"?
This is the process performed before starting a new batch to ensure the area is clean and free of previous materials.
What is "Line Clearance"?
This term describes a product, process, or document that meets all specified requirements.
What is “Conformity”?
These are the currently released products at Q'apel Medical.
What are Walrus, Armadillo, and Zebra?
This word should be written next to a mistake, followed by initials and date.
What is "void"?
Before performing any task, you must review this section of the SOP to understand the required materials and safety precautions.
What is the "Materials and Safety Requirements" section?
This is the most common method used during line clearance to verify that no materials or documents from the previous batch remain.
What is "Visual Inspection"?
This is the term used when a product or process fails to meet one or more specified requirements.
What is “Nonconformance”?
The new product currently in development at Q'apel Medical.
What is Falcon?
This principle ensures that entries are made at the time the activity is performed.
What is "contemporaneous"?
This is the action you must take if you notice an SOP is outdated or missing critical information.
What is "Initiate a Change Control"?
This document must be completed and signed off to confirm that line clearance has been successfully performed.
What is a "Line Clearance Checklist"?
This is the first thing you should do when you identify a nonconforming part on the production floor.
What is “Quarantine it” or “Report it”?
The new CEO Stewart "Stew" Strong has been with the company roughly how many months now.
What is roughly 4 months?
This acronym represents the key attributes of data integrity: Attributable, Legible, Contemporaneous, Original, and Accurate.
What is "ALCOA"?
This is the correct way to document that you followed an SOP during a production activity.
What is "Initial and date the step after completion"?
Failure to perform proper line clearance can lead to this type of serious quality event.
What is a "Cross-contamination" or "Batch Mix-up"?
This document is used to formally record the details of a nonconformance, including the issue, impact, and disposition.
What is a “Nonconformance Material Report (NCMR)”?
According to the Q'apel Medical Website, which month and year was the announcement of the move into the current facility.
What is July 2021?
This is the proper way to correct an error in a controlled document without obscuring the original entry.
What is "single-line strike-through with reason, initials, and date"?
This regulatory principle requires that SOPs be reviewed and approved by qualified personnel before implementation.
What is "Document Control"?
This regulatory principle requires that line clearance activities be documented, verified, and retained as part of the batch record.
What is "Good Documentation Practice (GDP)"?
This quality system element ensures that nonconforming product is identified, documented, evaluated, and prevented from unintended use.
What is “Control of Nonconforming Product”?
Between Walrus, Armadillo, and Zebra, the best Q'apel Medical product is.
What is "All of the above"?