U
ULPA Filter
Ultra-low penetration air filter with minimum 0.3 µm particle retaining efficiency of 99.999 percent. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Unauthorized Market / Parallel Market
The unauthorized market consists of wholesale establishments and retail outlets distributing or selling drugs without authorization from a competent authority. [Inspection, WHO]
Unblinding
The disclosure of the identity of a blinded product. [Directive 2003/94/EC]
Unexpected Adverse Reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. [Directive 2001/83/EC]
Unidentified Degradation Product
A degradation product for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). [ICH Q3B]
Unidentified Impurity
An impurity for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). [ICH Q3A, see also: ICH Q6A]
Unidirectional Airflow
An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Unidirectional airflow is a rectified airflow over the entire cross-sectional area of a clean zone with a steady velocity and approximately parallel streamlines (see also turbulent flow). (Modern standards no longer refer to laminar flow, but have adopted the term unidirectional airflow.) [Main Principles for Pharmaceutical Products, WHO]
Uniformity
A starting material may be considered uniform when samples drawn from different layers do not show significant differences in the quality control tests which would result in non-conformity with specifications. The following materials may be considered uniform unless there are signs to the contrary: organic and inorganic chemicals, purified natural products, various processed natural products such as fatty oils and essential oils, and plant extracts. The assumption of uniformity is strengthened by homogeneity, i.e. when the consignment is derived from a single batch. [Sampling Operations, WHO]
Unique Device Identifier (UDI)
An identifier that adequately identifies a device through its distribution and use by meeting the requirements of §830.20 of 21 CFR Part 820 Quality System Regulation. A unique device identifier is composed of:
The product identifier used to identify an item sold at retail in the United States. [21 CFR Part 820, FDA]
Universal TestA test which is considered to be potentially applicable to all new drug substances, or all new drug products, e.g., appearance, identification, assay, and impurity tests. [ICH Q6A]
Unplanned (Emergency) Change
An unanticipated necessary change to a validated system requiring rapid implementation, also known as a “hot-fix“. [PIC/S PI 011-3]
Unprocessed Bulk
One or multiple pooled harvests of cells and culture media. When cells are not readily accessible, the unprocessed bulk would constitute fluid harvested from the fermenter. [ICH Q5A]
Unspecified Degradation Product
A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification. [ICH Q3B]
Unspecified Impurity
An impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance specification. [ICH Q3A]
User(see also Regulated User)
The company or group responsible for the operation of a system. The GxP customer, or user organisation, contracting a supplier to provide a product. In the context of this document it is, therefore, not intended to apply only to individuals who use the system, and is synonymous with Customer. [PIC/S PI 011-3]
Utility Software
Computer programs or routines designed to perform some general support function required by other application software, by the operating system, or by system users. [PIC/S PI 011-3]
Ultra-low penetration air filter with minimum 0.3 µm particle retaining efficiency of 99.999 percent. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Unauthorized Market / Parallel Market
The unauthorized market consists of wholesale establishments and retail outlets distributing or selling drugs without authorization from a competent authority. [Inspection, WHO]
Unblinding
The disclosure of the identity of a blinded product. [Directive 2003/94/EC]
Unexpected Adverse Reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the summary of product characteristics. [Directive 2001/83/EC]
Unidentified Degradation Product
A degradation product for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). [ICH Q3B]
Unidentified Impurity
An impurity for which a structural characterisation has not been achieved and that is defined solely by qualitative analytical properties (e.g., chromatographic retention time). [ICH Q3A, see also: ICH Q6A]
Unidirectional Airflow
An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
Unidirectional airflow is a rectified airflow over the entire cross-sectional area of a clean zone with a steady velocity and approximately parallel streamlines (see also turbulent flow). (Modern standards no longer refer to laminar flow, but have adopted the term unidirectional airflow.) [Main Principles for Pharmaceutical Products, WHO]
Uniformity
A starting material may be considered uniform when samples drawn from different layers do not show significant differences in the quality control tests which would result in non-conformity with specifications. The following materials may be considered uniform unless there are signs to the contrary: organic and inorganic chemicals, purified natural products, various processed natural products such as fatty oils and essential oils, and plant extracts. The assumption of uniformity is strengthened by homogeneity, i.e. when the consignment is derived from a single batch. [Sampling Operations, WHO]
Unique Device Identifier (UDI)
An identifier that adequately identifies a device through its distribution and use by meeting the requirements of §830.20 of 21 CFR Part 820 Quality System Regulation. A unique device identifier is composed of:
- A device identifier – a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device, and
- A production identifier – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
- The lot or batch within a device was manufactured,
- The serial number of a specific device,
- The expiration date of a specific device,
- The date a specific device was manufactured.
- For an HCT/P regulated as a device, the distinct identification code required by §1271.290(c) of this chapter. [21 CFR Part 820, FDA]
The product identifier used to identify an item sold at retail in the United States. [21 CFR Part 820, FDA]
Universal TestA test which is considered to be potentially applicable to all new drug substances, or all new drug products, e.g., appearance, identification, assay, and impurity tests. [ICH Q6A]
Unplanned (Emergency) Change
An unanticipated necessary change to a validated system requiring rapid implementation, also known as a “hot-fix“. [PIC/S PI 011-3]
Unprocessed Bulk
One or multiple pooled harvests of cells and culture media. When cells are not readily accessible, the unprocessed bulk would constitute fluid harvested from the fermenter. [ICH Q5A]
Unspecified Degradation Product
A degradation product that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug product specification. [ICH Q3B]
Unspecified Impurity
An impurity that is limited by a general acceptance criterion, but not individually listed with its own specific acceptance criterion, in the new drug substance specification. [ICH Q3A]
User(see also Regulated User)
The company or group responsible for the operation of a system. The GxP customer, or user organisation, contracting a supplier to provide a product. In the context of this document it is, therefore, not intended to apply only to individuals who use the system, and is synonymous with Customer. [PIC/S PI 011-3]
Utility Software
Computer programs or routines designed to perform some general support function required by other application software, by the operating system, or by system users. [PIC/S PI 011-3]