Glossary

The combination of pressure and temperature at which the gas and liquid phases of a substance become indistinguishable.

Processing variable (temperature, pressure, level, pH, etc.), which may influence the final water or steam quality characterization or impurity profile.

(PQLI) A process parameter whose variability impacts a quality attribute and therefore needs to be controlled to ensure the process produces the desired quality. A critical process parameter remains critical even if it is controlled.

(ICH Q8 (R2)) A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.

For sterile products, this normally is an activity where product or product contact parts are exposed to the surrounding environment.

Attribute of the water or steam product which usually relates to the identity, purity, or quality of the water or steam product. Some attributes for water and steam are, contained levels of TOC, conductivity, microbial activity, etc.

(PQLI) A physical, chemical, biological or microbiological property of characteristic that needs to be controlled (directly or indirectly) to ensure product quality.

Attribute of the water or steam product which usually relates to the identity, purity, or quality of the water or steam product. Some attributes for water and steam are, contained levels of TOC, conductivity, microbial activity, etc.

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs are generally associated with the drug substance, excipients, intermediates (in process materials) and drug product. (ICH Q8 (R2) II 2.2)

(ICH Q8 (R2)) A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

Unit operation or processing step in which operation out of a specified range of controlled parameters could result in a product that is out of specification, but undetectable by routine measurement methods.

The point or points in the process which, if not carried out properly or if contaminated, will not allow drug substances to be made such that they will meet their intended characterizations and impurity profiles.

Step(s) after which a drug substance, which meets its intended characterization and impurity profile, cannot be made if there is a process malfunction or contamination. It is a step after which recovery from process malfunction or contamination is not possible.

The part of the working surface to be protected from particulate contamination. It is within the Critical Zone.

Structural, mechanical, or electrical system that can impact the processing parameters and attributes of the finished product or regulatory study. Critical systems may include utilities, process equipment and systems.

Is one that must be controlled within predetermined criteria to ensure that the API meets its specification.

Utility that has the identified potential to impact product quality or performance in a significant way.

In the case of WFI, it is the expectation that water samples will be taken from each point of use (POU) and sample point in the distribution system, at least once per week, although the widespread implementation of risk analysis tools may cause this expectation to be challenged in the future.

(IEEE) The degree of impact that a requirement, module, error, fault, failure, or other item has on the development or operation of a system. Synonym: Severity.

(IEEE) Analysis which identifies all software requirements that have safety implications, and assigns a criticality level to each safety-critical requirement based upon the estimated risk.

An evaluation process where the systems software functionality is assessed against the GxP, safety, and environmental critical parameters to enable accurate monitoring and control of the application during system development. The process uses a combination of system Risk Assessment and GAMP categorization of the system components.