L
Labelling
Information on the immediate or outer packaging. [Directive 2001/83/EC]
The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
Process of identifying a pharmaceutical product including the following information, as appropriate: name of the product, active ingredient(s), type and amount, batch number, expiry date, special storage conditions or handling precautions, directions for use, warnings and precautions, names and addresses of the manufacturer and/or the supplier. [Good Distribution Practices for Pharmaceutical Products, WHO]
Laboratory Information Management System (LIMS)
LIMS, like MES, belong to the plant management levels. They are used to record and document quality-related values e.g. for inspection of incoming goods or so-called In-Process Controls (IPC) for the process running time.
Laminar Flow
(see also Unidirectional Airflow (UDAF))
An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight line vector. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
The method that the air flows unidirectional with the stable symmetrical way and enough rate. It can continuously remove the particles at the critical operation area. [Chinese GMP Guidelines, Annex1]
Large-Volume Parental
Sterile solutions intended for parenteral application with a volume of 100 ml or more in one container of the finished dosage form. [Main Principles for Pharmaceutical Products, WHO]
Leukapheresis
Separation of leukocytes by removing whole blood from the donor, separating the leukocytes, and returning the formed elements and plasma back to the donor. [Canadian GMP Guidelines, Annex 14]
Leuko Reduced Component
Component units that have been treated by centrifugation, filtration or other methods to reduce the amount of leukocytes per unit to a level below a standard acceptable value. [Canadian GMP Guidelines, Annex 14]
Lifecycle
All phases in the life of a product from the initial development through marketing until the product’s discontinuation. [EU GMP Guide, Annex 15, ICH Q8]
Lifecycle Concept
An approach to computer system development that begins with (PMA CSVC) identification of the user’s requirements, continues through design, integration, qualification, user validation, control and maintenance, and ends only when commercial use of the system is discontinued. [PIC/S PI 011-3]
LigandAn agent with a strong affinity to a metal ion. [ICH Q3A]
Limit of Detection (LOD)
The lowest amount of analyte in a sample which can be detected but not quantitated as an exact value. The Limit of Detection is mostly a parameter of limit tests. [PIC/S PI 006-3]
Limit of Quantification (LOQ)
The lowest amount of analyte in a sample which can be quantitatively determined with defined precision and accuracy under the stated experimental conditions. [PIC/S PI 006-3]
Limit of Quantitation (LOQ)
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. [ICH Q2]
Liquefiable Gas
Those which, at the normal filling temperature and pressure, remain as a liquid in the cylinder. [EU GMP Guide, Glossary]
Liquefied Gas
A gas which, when packaged for transport, is partially liquid (or solid) at a temperature above –50 °C. [EU GMP Guide, Annex 6]
Long Term
TestingStability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. [ICH Q1A]
Look-back
Documented procedure to trace biological medicinal substances or products which may be adversely affected by the use or incorporation of animal or human materials when either such materials fail release tests due to the presence of contaminating agent(s) or when conditions of concern become apparent in the source animal or human. [EU GMP Guide, Annex 2]
The process of identifying current or previous donations from a donor subsequently confirmed positive for a transfusion-transmitted agent in order to identify and notify consignees and recipients of suspect blood components from that donor, and retrieve available components. A lookback may be initiated through a traceback investigation or by a report of seroconversion or infection in a donor. [Canadian GMP Guidelines, Annex 14]
Loop Testing
Checking the installed combination of elements characterising each type of input/output loop. [PIC/S PI 011-3]
Lotsee Batch
Lot Numbersee Batch Number
Lowest-Observed Effect Level (LOEL)
The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [ICH Q3C]
Information on the immediate or outer packaging. [Directive 2001/83/EC]
The action involving the selection of the correct label, with the required information, followed by line clearance and application of the label. [Guide to Good Storage Practices for Pharmaceuticals, WHO]
Process of identifying a pharmaceutical product including the following information, as appropriate: name of the product, active ingredient(s), type and amount, batch number, expiry date, special storage conditions or handling precautions, directions for use, warnings and precautions, names and addresses of the manufacturer and/or the supplier. [Good Distribution Practices for Pharmaceutical Products, WHO]
Laboratory Information Management System (LIMS)
LIMS, like MES, belong to the plant management levels. They are used to record and document quality-related values e.g. for inspection of incoming goods or so-called In-Process Controls (IPC) for the process running time.
Laminar Flow
(see also Unidirectional Airflow (UDAF))
An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight line vector. [Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – cGMP, FDA]
The method that the air flows unidirectional with the stable symmetrical way and enough rate. It can continuously remove the particles at the critical operation area. [Chinese GMP Guidelines, Annex1]
Large-Volume Parental
Sterile solutions intended for parenteral application with a volume of 100 ml or more in one container of the finished dosage form. [Main Principles for Pharmaceutical Products, WHO]
Leukapheresis
Separation of leukocytes by removing whole blood from the donor, separating the leukocytes, and returning the formed elements and plasma back to the donor. [Canadian GMP Guidelines, Annex 14]
Leuko Reduced Component
Component units that have been treated by centrifugation, filtration or other methods to reduce the amount of leukocytes per unit to a level below a standard acceptable value. [Canadian GMP Guidelines, Annex 14]
Lifecycle
All phases in the life of a product from the initial development through marketing until the product’s discontinuation. [EU GMP Guide, Annex 15, ICH Q8]
Lifecycle Concept
An approach to computer system development that begins with (PMA CSVC) identification of the user’s requirements, continues through design, integration, qualification, user validation, control and maintenance, and ends only when commercial use of the system is discontinued. [PIC/S PI 011-3]
LigandAn agent with a strong affinity to a metal ion. [ICH Q3A]
Limit of Detection (LOD)
The lowest amount of analyte in a sample which can be detected but not quantitated as an exact value. The Limit of Detection is mostly a parameter of limit tests. [PIC/S PI 006-3]
Limit of Quantification (LOQ)
The lowest amount of analyte in a sample which can be quantitatively determined with defined precision and accuracy under the stated experimental conditions. [PIC/S PI 006-3]
Limit of Quantitation (LOQ)
The quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy. The quantitation limit is a parameter of quantitative assays for low levels of compounds in sample matrices, and is used particularly for the determination of impurities and/or degradation products. [ICH Q2]
Liquefiable Gas
Those which, at the normal filling temperature and pressure, remain as a liquid in the cylinder. [EU GMP Guide, Glossary]
Liquefied Gas
A gas which, when packaged for transport, is partially liquid (or solid) at a temperature above –50 °C. [EU GMP Guide, Annex 6]
Long Term
TestingStability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling. [ICH Q1A]
Look-back
Documented procedure to trace biological medicinal substances or products which may be adversely affected by the use or incorporation of animal or human materials when either such materials fail release tests due to the presence of contaminating agent(s) or when conditions of concern become apparent in the source animal or human. [EU GMP Guide, Annex 2]
The process of identifying current or previous donations from a donor subsequently confirmed positive for a transfusion-transmitted agent in order to identify and notify consignees and recipients of suspect blood components from that donor, and retrieve available components. A lookback may be initiated through a traceback investigation or by a report of seroconversion or infection in a donor. [Canadian GMP Guidelines, Annex 14]
Loop Testing
Checking the installed combination of elements characterising each type of input/output loop. [PIC/S PI 011-3]
Lotsee Batch
Lot Numbersee Batch Number
Lowest-Observed Effect Level (LOEL)
The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals. [ICH Q3C]