Glossary

The use of ‘critical’ within this Guide means that the items have the identified potential to impact product quality or performance in a significant way. There may be other items, not associated with quality or performance, that have a significant impact on, for example, safety, environment, or operations, and these may need to be identified as ‘business critical’ items.

The use of ‘critical’ within this Guide means that the Items that have the identified potential to impact public health in a significant way, e.g., affecting product quality or drug safety data. There may be other items, not associated with public safety, that have a significant impact on, for example, economy, environment, or operations, and these may need to be identified as ‘business critical’ items.

An area where product or contact surface is exposed, normally Class 100 (e.g., Point of Fill).

(FDA 2004 Aseptic Processing Guidance) An area designed to maintain sterility or sterile materials. Sterilized products, containers, closures and equipment may be exposed in critical areas. Also called Critical Zone.

Are typically functions, features, abilities, and performance characteristics necessary for the manufacturing process and systems to ensure consistent product quality and patient safety. They should be identified and documented based on scientific product

Critical Aspects of manufacturing systems are typically functions, features, abilities, and performance or characteristics necessary for the manufacturing process and systems to ensure consistent product quality and patient safety.

A component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on the quality of the drug.

A component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on product quality or the ability to know product quality.

A component within a system where the operation, contact, data, control, alarm, or failure may have a direct impact on the quality of the product.

(QA) A function or an area in a manufacturing process or procedure, the failure of which, or loss of control over, may have an adverse affect on the quality of the finished product and may result in a unacceptable health risk.

(IEEE) A review conducted to verify that the detailed design of one or more configuration items satisfy specified requirements; to establish the compatibility among the configuration items and other items of equipment, facilities, software, and personnel; to assess risk areas for each configuration item; and, as applicable, to assess the results of producibility analyses, review preliminary hardware product specifications, evaluate preliminary test planning, and evaluate the adequacy of preliminary operation and support documents.

A device that directly ensures that a Critical process Parameter is maintained within predetermined limits.

A device that directly ensures that a GMP Critical Parameter is maintained within predetermined limits.

A dimension that if not maintained within specified limits has the potential to impact installation of a system or component in a significant way.

A device that measures and directly ensures that a Critical Process Parameter is maintained within predetermined limits.

These are the instruments used to measure critical parameters.

An instrument that will impact the quality of the product. It may control process parameters, alert an operator to an out of control condition, or be used only for indication.

A device that directly ensures that a GMP Critical Parameter is maintained within predetermined limits.

The instruments and systems which measure or control critical parameters.

The location where product is exposed; the location where a cleaned product contact surface is exposed.

Subset of process critical operational data (typically, measured values of critical quality attributes) that exists (measured or system generated) in electronic measurement and control systems. These data may depict the identity, purity, or quality of the water or steam product.

A GMP or product quality parameter (e.g., differential pressure, unidirectional airflow pattern) that must be maintained within predefined limits to ensure product SISPQ (Strength, Identity, Safety, Purity, or Quality).

These are the measured values that would determine process compliance and cause a system to revert to a fail-safe mode.

Processing parameter (temperature, pressure, pH etc.) which directly influences the drug substance characterization or impurity profile in or after a critical step.

A processing variable (temperature, pressure, pH, etc.) that directly influences the drug substance characterization or impurity profile in or after a critical step.