QA
This is the term for fixing a quality issue and putting measures in place to stop it from happening again.
CAPA (Corrective and Preventive Action)
What does QC micro do?
Monitors microbial contamination.
This is the abbreviation for the overarching set of quality policies and processes.
QMS (Quality Management Systems)
This US government agency conducts surprise inspections of biopharma companies.
FDA
What is the all-encompassing term that includes GMP, GLP, GCP, etc.?
GxP
If QC identifies an issue, this team creates the corrective strategy.
QA (Quality Assurance)
Quality Systems oversees this process of creating, reviewing, and updating documents.
Document control
A company might receive this document if it fails an FDA inspection.
483
Describe the purpose of GMP guidelines.
They ensure drugs are consistently manufactured and controlled according to quality standards.
If something doesn’t meet the standard, it’s called this.
A deviation
Name two electronic platforms commonly used for managing Quality Systems.
Veeva, MasterControl, Trackwise
In addition to preparing for FDA/regulatory inspections, auditors perform these two types of audits for their company.
Internal audits, supplier audits