Quality & Regulatory (GxP)

Quality and regulatory work under GxP: quality management systems, CAPAs, deviations and change control, data integrity and ALCOA, FDA inspections, 483s and warning letters.

Key terms & definitions

19 terms in this pack

ALCOA

Data must be Attributable, Legible, Contemporaneous, Original, Accurate (acronym)

AUDITTRAIL

The electronic log of who changed data and when (two words)

BATCHRECORD

The signed document proving exactly how a batch was made (two words)

CAPA

Corrective And Preventive Action fixing a problem and its root cause (acronym)

CHANGECONTROL

The process for reviewing and approving any process change (two words)

COMPLAINT

A reported product-quality or safety issue from the field

DATAINTEGRITY

Trustworthiness of records, judged by the ALCOA principles (two words)

GXP

Umbrella for the 'good practice' quality regs like GMP and GCP (acronym)

INSPECTION

An FDA visit that checks a facility for compliance

NONCONFORMANCE

A product or process that fails to meet a requirement

OBSERVATION

An item the FDA lists on a Form 483 after an inspection

OOS

Out-of-Specification lab result that triggers an investigation (acronym)

QMS

Quality Management System governing SOPs, CAPA and changes (acronym)

QUALIFICATION

Proving equipment works as intended: IQ, OQ and PQ

RECALL

Pulling a defective product back from the market

REMEDIATION

Fixing the compliance gaps found in an audit or inspection

ROOTCAUSE

The underlying reason a deviation occurred, found via a CAPA (two words)

SOP

Standard Operating Procedure staff are required to follow (acronym)

WARNINGLETTER

FDA notice citing serious violations after an inspection (two words)