Validation and Qualification in Analytical Laboratories-10-43.docx

Validation

The process of providing evidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

Verification

Confirmation by examination and provision of evidence that specified requirements have been met.

Qualification

A process that involves demonstrating that equipment works correctly and leads to expected results.

Calibration

The set of operations that establish, under specified conditions, the relationship between values indicated by a measuring instrument and the corresponding known values of the measurand.

GMP (Good Manufacturing Practice)

Regulations that ensure medicinal products are consistently produced and controlled according to quality standards appropriate to their intended use.

GLP (Good Laboratory Practice)

Regulations that provide a framework for the management of laboratory studies to ensure the integrity of data generated.

OQ (Operational Qualification)

The process of testing equipment in the selected user environment to ensure it meets previously defined functional and performance specifications.

PQ (Performance Qualification)

The process of testing that a system performs as intended for the selected application.

FDA

U.S. Food and Drug Administration, an agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs and other related products.

ISO 17025

International standard specifying general requirements for the competence of testing and calibration laboratories.

Risk Management

A systematic process of identifying, assessing, and controlling risks that may affect the quality of results.

Out-of-Specification (OOS)

Results that do not conform to established specifications or acceptance criteria.

Design Qualification (DQ)

A documented assessment of the suitability of the proposed design or project.

Computerized System Validation

The process of proving that a computerized system is suitable for its intended purpose.

Documentation

Recorded information that provides evidence of processes, procedures, or results.

Audit Trail

A record that traces steps or activities related to data handling and processes in a laboratory.

Proficiency Testing

A method to evaluate the performance of laboratories by comparing their results with those from other laboratories on the same sample.

Control Charts

Statistical tools used to monitor and control processes by displaying data over time.

Quality Assurance (QA)

A way of preventing errors or defects in manufactured products and avoiding problems when delivering solutions or services to customers.

Accreditation

Formal recognition that an organization is competent to carry out specific tasks.

Compliance

The action of conforming to a rule, such as a specification, policy, standard, or law.