Cleanroom Behavior
Last item during gowning.
What are gloves?
In GDP if you make a mistake on paper, this is how you correct it.
What is draw a single line through, initial, date, and add a footnote?
A deviation is documented when this occurs.
What is a departure from an SOP or expected process?
Every label must include this to ensure identification.
What is a lot/batch number?
The CTGEF Cleanrooms are this Class and ISO level.
What are Class 10,000/ ISO 7?
Move this slowly while in the BSC.
What are your arms/hands?
This phrase explains why we never use pencils in GDP.
CAPA stands for this.
Corrective and Preventive Actions
This document tracks every step of a product's journey.
What is a batch process record?
The cleanrooms must have this many or fewer particles per cubic foot.
What is 10,000 particles?
You should do this if you drop an item on the floor.
What is discard it and get a new one?
The rule that says if it wasn't documented, it didn't happen.
What is ALCOA?
You must initiate this as soon as a deviation is discovered.
What is a deviation report/investigation?
Materials must be labelled with this info even when in quarantine.
What is status (e,g. quarantine, released, or rejected)?
These two types of particles are typically monitored.
What are viable and non-viable particles?
Before entering the cleanroom, this part of your gowning must be on.
What is a mask?
You must record data at this time.
What is contemporaneously?
This tool is used to determine root cause.
What are the 5 whys?
Cross-contamination risk is mitigated by doing this with labels.
What is label reconcilliation and proper disposal?
Failure of temperature and humidity controls within the cleanroom may result in this before processing can resume.
What is a terminal cleaning?
This invisible enemy is one of the biggest concerns in cleanroom environment.
What are particles/contamination?
These are the five principles of data integrity.
What is Attributable, Legible, Contemporaneous, Original, and Accurate?
Preventive actions are implemented to do this.
What is prevent recurrence of the issue?
To ensure traceability, this must be maintained for raw materials.
What is an audit trail or material log?
A sudden spike in counts during routine monitoring may indicate this.
What is loss of laminar flow or contamination event?