CGMP key terms

A structured process for eliminating the cause of a detected nonconformity and preventing recurrence or occurrence elsewhere, comprising investigation, root cause analysis, action planning, implementation, and effectiveness verification.

Any departure from an approved instruction, specification, or established procedure. Deviations are documented, classified by impact, investigated, and closed with justification before batch disposition decisions are finalized.

A systematic method such as the five-whys, fishbone diagram, or fault tree used to identify the underlying system failure that allowed a problem to occur, rather than the immediate symptom.

A planned verification, performed after CAPA implementation, that confirms the action actually eliminated or reduced the problem, using predefined criteria and a defined observation period.

The removal or correction of a marketed product that violates regulations or poses a health hazard, classified by severity and executed through a documented, tested procedure with reconciliation of returned quantities.

The documented process of receiving, evaluating, investigating, and responding to product quality complaints, including assessment for potential recall and trending for adverse quality signals.

A simulated recall exercise performed to test whether the traceability system and notification procedures can locate and account for distributed product within a defined time target.

The formal structure of responsibilities, procedures, processes, and resources that directs an organization toward consistently meeting quality requirements and regulatory expectations.

A brief top-management statement defining the organization's overall quality intentions and direction, providing the framework against which quality objectives are established and reviewed.

A scheduled senior-management evaluation of the quality system's continuing suitability and effectiveness, using inputs such as audit results, complaints, CAPA status, and change control trends.

A systematic process for assessing, controlling, communicating, and reviewing risks to product quality across the lifecycle, commonly applying tools such as FMEA, HACCP, and risk ranking.

The independent organizational function with authority to approve or reject materials, batches, specifications, and procedures, and to ensure no conflicting production responsibilities compromise its decisions.

A planned, independent examination of the quality system and its procedures to verify compliance and effectiveness, with findings classified and tracked to closure through corrective actions.

A periodic aggregate evaluation of batch records, deviations, complaints, returns, stability data, and change controls for a product, used to confirm process consistency and identify improvement opportunities.

Documented evidence that an employee has the education, training, and experience required for assigned tasks, with training effectiveness assessed before independent work is authorized.

A retained document showing which training an individual completed, when, by whom it was delivered, and how competence was verified, supporting the training program's traceability.

A documented demonstration that an operator can correctly don and doff required garments and that the gowning practice achieves the specified cleanliness, verified by periodic requalification and microbiological monitoring.

The designation of an area by permitted airborne particle concentration at rest and in operation, with associated limits for viable contamination and recovery time after activity.

Documented verification that heating, ventilation, and air-conditioning systems deliver specified air change rates, pressure differentials, filtration, temperature, and humidity under defined operating conditions.

A three-phase program proving a pharmaceutical water system consistently produces water meeting specification, including sampling over extended periods and establishing routine monitoring and sanitization limits.

The staged documented evidence that equipment is installed as specified, operates as intended across its operating ranges, and performs consistently under production conditions.

The comparison of an instrument's measurement against a traceable reference standard of known accuracy, with results documented and acceptance criteria applied before the instrument is used.

A scheduled program of inspection, servicing, and part replacement intended to keep equipment in a qualified state and prevent failures that could affect product quality.

The practice of entering data at the time the activity is performed, so that records reflect actual events rather than later reconstruction from memory or secondary sources.

The completeness, consistency, accuracy, and reliability of data throughout its lifecycle, supported by controls over access, audit trails, review, retention, and secure archiving.

A secure, computer-generated, time-stamped record that allows reconstruction of who created, modified, or deleted electronic records, and why, without obscuring prior values.

An expectation that records be attributable, legible, contemporaneous, original, and accurate, plus complete, consistent, enduring, and available throughout retention.

A legally binding computer-based signature component that identifies the signer, is linked to the signed record, and cannot be excised or transferred to falsify another record.

A documented examination of the executed batch record and associated records before release, confirming critical steps, yields, and in-process results met approved requirements.

Checks performed during production, such as weight, hardness, pH, or bioburden, to monitor and adjust the process so the output conforms to specification.

Documented evidence that a cleaning procedure consistently reduces residues of product, cleaning agents, and microbes to predetermined acceptable limits, supported by recovery studies and worst-case product selection.

The unintended transfer of material or organisms from one product, surface, or area to another, controlled through dedicated facilities, cleaning, airlocks, and material flow design.

The documented assessment of a material supplier's ability to meet quality requirements, using questionnaires, audits, sample testing, and ongoing performance monitoring, with approved status maintained.

A controlled list of suppliers authorized to provide specified materials, maintained by the quality unit and updated only through the change control and qualification process.

A supplier-issued document reporting test results for a specific lot, which the receiving organization verifies against its own specifications and may confirm by limited identity testing.

The ability to follow a batch forward to distribution and backward to its components and packaging through recorded lot numbers and distribution records.

A test result outside established specification or acceptance criteria, requiring a documented laboratory investigation with defined phases before any retest, resample, or rejection decision.

A highly characterized material of established quality and purity used as the measurement basis in assays and calibrations, stored and requalified under controlled conditions.

A documented scheme defining sample size, sampling locations, frequency, and technique, chosen so results are representative of the lot and statistically support the intended decision.

A top-level document defining the scope, approach, responsibilities, acceptance criteria, and schedule for validation and qualification activities across a facility or project.

Documented evidence that a manufacturing process, operated within defined parameters, consistently produces product meeting specifications, established through initial, ongoing, and where needed revalidation.

A formal system for proposing, assessing, approving, implementing, and documenting changes to facilities, equipment, materials, or procedures, including evaluation of regulatory impact and requalification needs.