Definitions
A documented process used to perform root cause analysis to provide corrective actions to prevent re-occurrence.
What is an Investigation
Single line through, initial and date
What is how to correct an error
This is conducted at least yearly, and is required by FDA
What is GMP training
This is what cGMP stands for
What are Current Good Manufacturing Practices
This is abbreviated as OOS
What is Out of Specification
This document is used by FDA inspectors to communicate deficiencies observed during an inspection
What is a Form 483
All forms and batch records must be filled out in this
What is real time (contemporaneously)
All personnel must have training before performing these tasks
What are any GMP-related activities
This is what CFR stands for
What is the Code of Federal Regulations
This occurs if an OOS result confirms upon retest.
What is open a deviation
Action(s) taken to eliminate an identified non-conformance.
What is Corrective Action Preventative Action (CAPA)
Any Labeling or packaging materials that do not meet specifications shall be THIS to prevent their use in operations for which they are unsuitable.
What is rejected
This needs to be maintained on a continuous basis
What are training records
Following the rules and regulations in the CFR allows us to produce products that are safe, pure, and THIS
What is effective
All raw materials and packaging that meet specification receive this.
What are green Approval stickers
An atypical, abnormal, or unplanned incident or event
What is a deviation
Components, drug product containers, and closures approved for use shall be rotated so that this stock is used first
What is the oldest
This person stole Christmas
Who is the Grinch
This unique identifier is assigned to each finished product
What is a lot number
The initials and dates of this many people are required on laboratory records and logbooks (minimum number)
What are two
Additional instructions or steps that depart from an established approved procedure and are approved by the appropriate department and QA.
What is a Planned Deviation
Material under investigation shall be identified and controlled under this system
What is quarantine
Area Managers and QA are responsible for conducting annual reviews of these
what are curricula
Quality is the responsibility of these people
Who is everyone
What is escalate to management