Complaints
This Department owns complaint intake and logging.
What is the Quality Department?
This action is taken to prevent occurrence of a potential problem before it happens
What is a preventative action?
Cleaning up shared spaces shows this.
What is respect?
This system is where you log deviations, complaints, create change controls, and CAPAs (and maybe cry a little).
What is the QMS (e.g., Veeva)?
This neurotoxin is the active pharmaceutical ingredient in Myobloc.
What is Botulinum Toxin Type B?
This type of complaint suggests a significant impact to patient safety
What is a critical complaint?
This diagram organizes causes into categories like people, process, and equipment.
What is a Fishbone diagram?
Joining meetings on time demonstrates this.
What is professionalism?
This acronym stands for rules we follow to keep products safe and compliant.
What is cGMP?
A measure of how well two peaks are separated.
What is resolution?
This identifier connects a complaint to a specific batch.
What is the lot number?
This process is used to identify the root cause or most probable root cause of a problem or issue.
What is an investigation?
Good meetings always include this.
What is an agenda?
This ensures changes are reviewed and approved before implementation
What is change control?
A peak tailing factor significantly greater than this value may indicate poor chromatography.
What is 2.0?
A cracked tablet or bubble in vial falls under this type of issue.
What is a product defect?
This confirms that corrective actions worked.
What is a (CAPA) effectiveness check?
Always do this before hitting send.
What is proofread?
Storage of where physical GMP Records are archived.
What is the GxP Records Room?
This term describes the dose expected to cause death in 50% of a test population.
What is LD50?
This process is used to ensure that customer complaints provided by Contract PV Provider is aligned with data received by Supernus.
What is reconciliation?
Reviewing similar complaints to spot patterns is called this.
What is trending?
Acknowledging others’ work shows this.
What is teamwork?
World Quality Day this year (Hint: Date)
What is a 12 November 2026?
USP Apparatus 2 is commonly known as this.
What is the paddle apparatus?