CGMP flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

ALCOA+ data attributes

Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. These attributes define acceptable GMP records and are the basis for data integrity audits and inspections.

Annual product quality review

A periodic review of batch records, deviations, complaints, OOS results, changes, and stability data for a product, used to verify process consistency and identify needed improvements or revalidation.

Quality unit independence

The quality unit has authority to approve or reject materials, batches, and specifications independent of production management. This structural separation prevents commercial pressure from overriding quality decisions.

Management review

A scheduled review by senior management of quality metrics, audit findings, regulatory actions, and resource adequacy, producing documented decisions and assigned actions with due dates.

Training effectiveness assessment

Verification that personnel can perform a task correctly after training, using observation, testing, or performance qualification rather than attendance records alone.

Gowning qualification

Documented demonstration that personnel can don and doff cleanroom garments correctly for a specific grade, requalified periodically and required before entry to Grade A/B areas.

Personnel hygiene exclusion

Personnel with open lesions, illness, or communicable conditions that could affect product quality are excluded from direct product contact until cleared under a documented procedure.

Grade A in-operation particles

At ≥0.5 µm the limit is 3,520 particles/m³ and at ≥5 µm it is 20 particles/m³, measured while equipment runs and personnel are present.

Pressure differential rule

Adjacent areas of different cleanliness maintain typically at least 10 Pa difference, with airflow directed from cleaner to less clean areas; differentials are monitored and alarmed.

Viable monitoring limits

Typical active air limits per 4 hours: Grade A under 1 CFU, Grade B 5 CFU, Grade C 50 CFU, Grade D 100 CFU. Site programs define exact limits and methods.

Temperature mapping

A study using multiple probes to demonstrate uniform storage conditions across a warehouse or chamber, including worst-case locations, rather than relying on a single monitoring point.

Calibration traceability

Calibration must link to a national or international standard through an unbroken chain of comparisons, with documented certificates and defined intervals justified by criticality and history.

Out-of-calibration impact

When a calibration fails, all data and batches generated since the last valid calibration are assessed for impact, and the event is handled as a deviation.

Equipment qualification sequence

The lifecycle order is user requirements specification, design qualification, installation qualification, operational qualification, performance qualification, then periodic review and requalification as needed.

Audit trail review

A routine, risk-based review of electronic audit trails to detect unauthorized changes, deletions, or data manipulation; frequency and scope are defined in the data governance program.

Record correction rule

Corrections to GMP records use a single line through the error, the correct entry, date, initials, and a reason where required, preserving the original entry legibly.

Critical process parameter

A process input whose variability affects a critical quality attribute and therefore must be monitored or controlled within a proven acceptable range established during process validation.

Yield reconciliation

Comparison of theoretical and actual yield for each batch; variance beyond established limits requires investigation and quality approval before batch release.

Line clearance

A documented check that the line is free of previous product, components, and documents before starting a batch or campaign, preventing mix-ups and cross-contamination.

Supplier qualification

A documented evaluation of a supplier including audit or questionnaire, quality agreement, and periodic review, required before materials are used in GMP production.

FEFO material rotation

First expired, first out: materials with the earliest expiry or retest date are used first, with expired stock segregated and dispositioned rather than returned to inventory.

OOS phased investigation

An out-of-specification result is first investigated for laboratory assignable cause, then for manufacturing cause; the original result stands unless invalidation is scientifically justified and documented.

System suitability

Checks performed before and during an analytical run, such as resolution, tailing, and replicate precision, confirming the system is suitable for the intended analysis.

Reference standard control

Reference standards are qualified, stored per label, and periodically requalified; working standards are traceable to a primary standard with documented potency assignment.

Process performance qualification

Stage 2 of process validation demonstrating reproducible commercial-scale performance, conventionally requiring at least three consecutive successful batches with predefined acceptance criteria.

Cleaning validation limits

Acceptance limits for residues, cleaning agents, and microbes are derived from health-based exposure limits or a documented safety factor, with validated recovery and sampling methods.

Change control classification

Changes are categorized by impact on product quality, validation status, and regulatory filings; classification determines required testing, revalidation, and notification before implementation.

Class I recall

A recall of product with a reasonable probability of causing serious adverse health consequences or death, requiring the most urgent notification and effectiveness checks.

Recall effectiveness check

Verification that consignees received and acted on a recall notice, measured against a target response rate; the recall closes only when the check meets that target.

CAPA effectiveness verification

A planned check with a defined metric and timeframe confirming that corrective and preventive actions eliminated the root cause; repeating deviations indicate the CAPA failed.

Health hazard evaluation

An assessment of product, population, dose, and distribution extent used to judge the risk from a complaint or recall, documented and approved by the quality unit.

Deviation impact assessment

A documented evaluation of whether an event affects identity, strength, quality, purity, or safety, determining classification and the batch disposition decision.