CPGP flashcards
CPGP · Build recall with a focused review session.
20 cards. Read the term and the definition here. The deck at the top of this page is optional.
- Acceptance criterion
- A predefined condition used to judge a result against the intended requirement, distinct from inventing a passing limit after observing the data.
- Qualification
- Documented evidence about equipment installation, operation or performance under defined conditions, whose scope must match the intended product and process.
- Validation
- Documented evidence that the defined process can consistently meet specified requirements under its intended conditions, rather than one convenient passing result.
- Change control
- A documented assessment and authorization process for a proposed change, including its effects on existing evidence, specifications and responsibilities.
- Deviation
- A departure from an instruction, specification or expected condition that requires assessment rather than concealment or automatic acceptance.
- Corrective action
- An action directed at the supported cause of a detected problem, distinguished from merely correcting the individual affected record or item.
- Effectiveness check
- A planned evaluation of whether the implemented action achieved the intended result and controlled the identified problem under relevant conditions.
- Traceability
- The documented connection among materials, equipment, process versions, product lots and decisions, supporting investigation and identification of affected output.
- Calibration
- Comparison of a measurement system with an appropriate reference under stated conditions, including interpretation of error and relevant uncertainty.
- Data integrity
- The maintenance of trustworthy records throughout their lifecycle, including their origin, completeness, accuracy and appropriate handling of corrections.
- Audit criterion
- A specified requirement used to compare objective evidence during an audit, distinct from an auditor personal preference or unsupported opinion.
- Objective evidence
- Relevant information supporting a conclusion through observation, measurement, records or other examinable means, rather than assertion alone.
- Bioburden
- The population of viable microorganisms associated with a defined product or material at the specified point before a sterilization process.
- Sterility assurance level
- A specified probability concept used in sterilization process design and validation, distinguished from proof obtained by examining every finished unit.
- Process challenge device
- A defined challenge used to assess relevant sterilization performance, whose suitability depends on the process, product and intended challenge.
- Biological indicator
- A characterized microbiological challenge used under specified conditions to provide evidence about a process, without independently proving every product unit sterile.
- Chemical indicator
- A device responding to defined process conditions, whose response must be interpreted according to its type and intended application.
- Product family
- A justified grouping of products sharing relevant characteristics for a defined assessment, rather than any convenient collection with a common label.
- Quarantine
- A controlled status preventing unintended use or release while the required evaluation or disposition remains incomplete, with appropriate physical or system controls.
- Risk assessment
- A structured examination of hazards, likelihood, consequences and controls within the stated context, supporting decisions without removing every uncertainty.