GMP Glossary & Definitions
Target Level:
The term target level is commonly used in specifications to define the formulated value.
Technical Agreement, Technical Quality Agreement, TQA:
A technical agreement sometimes also called quality agreement or quality technical agreement is a contract agreement which states the manufacturing and quality control provisions as well as the GMP provisions required. The rules should be stated as part of this Agreement (e.g. immediate information about changes in production or manufacturing failures).
Technical Training:
In the GMP environment the technical training is any kind of training relevant to technical operations and maintenance in order to acquire and develop technical knowledge and skills to perform a certain task.
Theoretical yield:
The quantity that would be produced at any appropriate phase of manufacture, processing, or packing of a particular API or intermediate, based upon the quantity of components to be used, in the absence of any loss or error in actual production.
Therapeutic category:
Group of drugs intended to treat or cure a particular disease or related diseases. Several of these categories are antibiotics (drugs that prevent, inhibit or destroy microorganisms), cardiovascular (drugs that treat diseases of the heart and blood vessels), hypnotics (drugs that induce sleep), and nonsteroidal anti-inflammatory drugs or NSAIDs (drugs used to treat pain, fever and swelling).
Third Party Manufacturing:
The term Third Party Manufacturing is used for outside contract manufacturers, testing laboratories or packagers.
Toxic Impurity:
A toxic impurity is any impurity having significant undesirable biological activity.
Toxicology:
Scientific discipline concerning the identification and effects of poisons and the treatment of poisoned individual.
Toxicology safety and testing:
Group of tests to determine the potential risk of a compound to man and the environment. These studies involve the use of animals, tissue cultures and other test systems to examine dose level, frequency of administration, and duration on the dose-response pattern of the compound and its toxic side effects. Most toxicology and safety testing is conducted before its human introduction.
TRx:
A measure of total prescriptions (new and refills) issued in a given time period.
Training - Formal:
The systematic development of knowledge, skills and attitudes required by an individual to perform adequately a given task or job, through courses that may be presented externally or internally.
Training On-the-job:
The Training- On-the-job is the development of knowledge, skills and attitudes through training in the workplace. Training methods may include verbal instruction, physical demonstration, including group discussion, simulation, case studies and surveys.
Training Master Plan:
The training master plan is a document describing a general as well as the mid and long term program that is designed to address employee training in regard to quality, compliance, technical and organizational objectives.
Transportation:
The movement of Material or Product by any conveyance between a point of origin to the point of designation.
