N
Negative Control
Refers to the sterility test controls that may be used to identify a "false positive" test result. Growth in the media sterility test, or environmental monitoring, or negative product controls may contribute to the verification of a ""false positive"" test finding and an invalid test result. [PIC/S PI 012-3]
Negative Product Control
Product or simulated product of known or undoubted sterility that is tested during the same test session as the product test samples. Negative product controls should be exposed to a terminal sterilisation process, such as exposure to steam sterilisation, gamma-irradiation etc, and be packaged in a similar manner to the test sample in terms of manipulations required of the test operator. [PIC/S PI 012-3]
Network
(a) An interconnected, or interrelated group of nodes.
(b) An interconnected communications facility. A local Are Network (LAN) is a high bandwidth (allowing a high data transfer rate) computer network operating over a small area such as an office or group of offices. [PIC/S PI 011-3]
Neurotoxicity
The ability of a substance to cause adverse effects on the nervous system. [ICH Q3C]
New Drug Product
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients. [ICH Q6A]
New Drug Substance
The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved drug substance. [ICH Q3A, Q3B, Q6A]
New Molecular Entity
An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance. [ICH Q1A]
No-Carrier-Added
Indicates the status of a radionuclide sample where no stable atom of the same element has been added purposely. [Canadian GMP Guidelines, Annex 3, Annex 5]
No-impact System
This is a system that will not have any impact, either directly or indirectly, on product quality. These systems are designed and commissioned according to GEP only. [Main Principles for Pharmaceutical Products, WHO]
No-Observed-Effect Level
The highest dose of substance at which there are no biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [ICH Q3C]
Non-conformity
The nonfulfillment of a specified requirement. [21 CFR 820, FDA] A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Non-critical Parameter / Non-critical ComponentA processing parameter or component within a system where the operation, contact, data control, alarm or failure will have an indirect impact or no impact on the quality of the product. [Main Principles for Pharmaceutical Products, WHO]
Non-endogenous Virus
Viruses from external sources present in the Master Cell Bank. [ICH Q5A]
Non-interventional Trial
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Directive 2001/20/EC]
Non-return Valve
Valve, which permits flow in one direction only. [EU GMP Guide, Annex 6]
Non-specific Model VirusA virus used for characterisation of viral clearance of the process when the purpose is to characterise the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterise the robustness of the purification process. [ICH Q5A]
Nonfiber Releasing Filter
Any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. [21 CFR Part 210, FDA]
Normal Operating Range
The range that the manufacturer selects as the acceptable values for a parameter during normal operations. This range must be within the operating range. [Main Principles for Pharmaceutical Products, WHO]
Refers to the sterility test controls that may be used to identify a "false positive" test result. Growth in the media sterility test, or environmental monitoring, or negative product controls may contribute to the verification of a ""false positive"" test finding and an invalid test result. [PIC/S PI 012-3]
Negative Product Control
Product or simulated product of known or undoubted sterility that is tested during the same test session as the product test samples. Negative product controls should be exposed to a terminal sterilisation process, such as exposure to steam sterilisation, gamma-irradiation etc, and be packaged in a similar manner to the test sample in terms of manipulations required of the test operator. [PIC/S PI 012-3]
Network
(a) An interconnected, or interrelated group of nodes.
(b) An interconnected communications facility. A local Are Network (LAN) is a high bandwidth (allowing a high data transfer rate) computer network operating over a small area such as an office or group of offices. [PIC/S PI 011-3]
Neurotoxicity
The ability of a substance to cause adverse effects on the nervous system. [ICH Q3C]
New Drug Product
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc., which has not previously been registered in a region or Member State, and which contains a drug ingredient generally, but not necessarily, in association with excipients. [ICH Q6A]
New Drug Substance
The designated therapeutic moiety that has not been previously registered in a region or member state (also referred to as a new molecular entity or new chemical entity). It can be a complex, simple ester, or salt of a previously approved drug substance. [ICH Q3A, Q3B, Q6A]
New Molecular Entity
An active pharmaceutical substance not previously contained in any drug product registered with the national or regional authority concerned. A new salt, ester, or non-covalent-bond derivative of an approved drug substance is considered a new molecular entity for the purpose of stability testing under this guidance. [ICH Q1A]
No-Carrier-Added
Indicates the status of a radionuclide sample where no stable atom of the same element has been added purposely. [Canadian GMP Guidelines, Annex 3, Annex 5]
No-impact System
This is a system that will not have any impact, either directly or indirectly, on product quality. These systems are designed and commissioned according to GEP only. [Main Principles for Pharmaceutical Products, WHO]
No-Observed-Effect Level
The highest dose of substance at which there are no biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [ICH Q3C]
Non-conformity
The nonfulfillment of a specified requirement. [21 CFR 820, FDA] A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements. [Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA]
Non-critical Parameter / Non-critical ComponentA processing parameter or component within a system where the operation, contact, data control, alarm or failure will have an indirect impact or no impact on the quality of the product. [Main Principles for Pharmaceutical Products, WHO]
Non-endogenous Virus
Viruses from external sources present in the Master Cell Bank. [ICH Q5A]
Non-interventional Trial
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorisation. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Directive 2001/20/EC]
Non-return Valve
Valve, which permits flow in one direction only. [EU GMP Guide, Annex 6]
Non-specific Model VirusA virus used for characterisation of viral clearance of the process when the purpose is to characterise the capacity of the manufacturing process to remove and/or inactivate viruses in general, i.e., to characterise the robustness of the purification process. [ICH Q5A]
Nonfiber Releasing Filter
Any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. [21 CFR Part 210, FDA]
Normal Operating Range
The range that the manufacturer selects as the acceptable values for a parameter during normal operations. This range must be within the operating range. [Main Principles for Pharmaceutical Products, WHO]