A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Label

A label is defined as the product identifier including patient instructions that are placed on the primary container.

Labeling

Labeling is defined as the process when a label is put on a product.

or

Printed materials that accompany a prescription drug when shipped in interstate commerce.

Laboratory Scale:
A Laboratory scale is a small batch size production of drug product or drug substance / Active pharmaceutical ingredient (API) under laboratory conditions.

License-Product License

The license is the registration containing the regulatory requirements for a product, such as Market Application Authorization (MAA) or New Drug Application (NDA).

Lifecycle

The term Lifecycle is commonly used in relationship to the entire lifetime of a product or process. This may start from design, development, realization, validation, production, change control, process improvements and re-validation until the product or process ends.

Ligand

An agent with a strong affinity to a metal ion. 

Limit of Detection

The term limit of detection is used for the lowest level of analyte that can be detected using a specific method under the required conditions.

Limit of Quantitation

The term limit of quantitation is used for the lowest concentration of analyte in a sample that may be determined with acceptable accuracy and precision when the required method is applied.

Line Clearance

The term line clearance is used for the documented act of conducting any necessary removal of products and materials from a manufacturing line to prepare the line for the next production (packaging).

Line Segregation

The term line segregation describes the usage of a physical separation of lines, usually done with a physical wall or barrier (packaging).

Load Configuration

The term load configuration is the pre-defined, documented description of the exact configuration of material or product when entering a lyophilizer or sterilizer (e.g. autoclave).

Long Term Stability

The term long term stability describes a stability evaluation of the physical, chemical, biological and microbiological characteristics of a material or product. The long term stability should cover the expected duration of the shelf life that is claimed in the submission and will appear on the Labeling of the product.

Lot

Please refer to batch.

or

A batch, or a specific identified portion of a batch having uniform character and quality within specified limits. For an API produced by continuous process, it is a specific identified amount produced in a unit of time or quantity in a manner that ensures its having uniform character and quality within specified limits.

Lot Number-control number or batch number

Please refer to batch number.

or

Any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of an API or other material can be determined.