These are loose pieces of paper that may contain instrument printouts, customer communication records, or certificates that are attached to a laboratory notebook.
What are ADRs
100
An atypical, abnormal, or unplanned incident or event
What is a deviation
100
To witness or check another individual's observation and calculations
What is technical or data review
100
A status given to manufacturing materials when testing fail specification
What is Non-conforming
100
The Compliance Policy Document that describes the overall approach to Manufacturing and Clinical Packaging Operations
What is CPD9000
200
The area of the notebook where "circle notes" in the working space are defined.
What are "Notes and Comments"
200
The single, specific underlying cause for a deviation
What is a root cause
200
Task performed by labware users before submitting labware for cleaning
What is rinsing/decontaminate/pre-cleaning of glassware
200
This is the form used to transfer samples for testing to Materials Control after manufacture.
What is Laboratory Material Receipt form
200
The equipment identification number (EIN) assigned to the manufacturing area.
What is EIN9000-C0008
300
The SOP # of the procedure describing how to change an SOP, form, or approved template.
What is SOP1000-C0003
300
The department of Advantar that must be notified of any deviations
What is Quality Assurance or Area Management
300
The only type of equipment that does not require to be green stickered.
What is a general purpose equipment
300
Types of materials that cannot be released without an expiration date
What are manufacturing raw materials (e.g. API, excipients, inactive ingredients/materials)
300
The ISO classification assigned to Rooms 3 and 4 of the manufacturing areas
What is ISO class 8
400
This is the process performed at the completion of a project, equipment/computer qualification, after review of notebooks and report(s) are completed for each stage of protocol.
What is a "Closeout"
400
Short term or immediate action(s) taken to address the definitive or potential root cause(s) for a deviation
What is corrective action
400
The process that qualifies Advantar to use a certain analytical test method/procedure validated in another laboratory
What is Method Transfer
400
The expiration date used for "in use" purified or analytical grade water
What is 1 month
400
The document created and used to assign a part number to manufacturing materials
What is a Specification document
500
The only section/area of the notebook where raw data are allowed to be pasted.
What is a "Working Space"
500
The target completion, in days, for deviations
What is 30 days (for deviations)
500
Equipment under UM needs to be tagged with this
What is a "red sticker" or "Equipment out of use" label
500
The type of laboratory material that requires Certificate of analysis to be attached to a CMR.
What is a Reference standard
500
The CMR form used as a ADV lot # for manufacturing raw materials