Glossary

(ICH Q5E) A molecular or product characteristic that is selected for its ability to help indicate the quality of the product. Collectively, the quality attributes define identity, purity, potency and stability of the product, and safety with respect to adventitious agents. Specifications measure a selected subset of the quality attributes.

Characteristics that define the suitability of a system/process.

Characteristics that define the suitability of a system/process.

A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.

(PQLI) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and Quality Risk Management.

(ICH Q8 (R2)) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and Quality Risk Management.

Checking or testing, that specifications are met, or the regulatory process through which the industry measures actual quality performance, compares it with standards, and acts on the difference.

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(ICH Q7)Checking or testing that specifications are met.

Process or group responsible for coordinating the activities associated with analytical test planning and execution.

The operational techniques and procedures used to achieve quality requirements.

Group responsible for checking or testing that specifications are met.

The operation techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

The group who enforces the GMP regulations.

The entire collection of activities from which the industry achieves fitness for use, no matter where these activities are performed.

The quality of the product can be impacted by a system or systems which meets any of the following criteria: in contact with product, used as an excipient of ingredient, an/or controls or provides information relative to product acceptance or rejection.

Provides real time analysis of measurements collected from manufacturing to assure proper product quality control and to identify problems requiring attention. It may recommend action to correct the problem, including correlating the symptom, actions, and results to determine the cause. May include SPC/SQC tracking and management of off-line inspection operations, and analysis from a laboratory information management system (LIMS) could also be included.

(ISO) The organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

(ISO) Management system to direct and control an organization with regard to quality.

Management system to direct and control an organization with regard to quality (e.g., ISO). This is equivalent to Quality System as defined in ICH Q9.

(ICH Q10) Document specifying the quality management system of an organization. (ISO 9000:2005)

(ICH Q10) A means to translate the quality policy and strategies into measurable activities.

(ISO) Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract.

A document setting out the specific quality practices, resources, and sequence of activities relevant to a particular product, project, or contract.