GMP Requirements--terms Flashcards
active ingredient or active pharmaceutical ingredient (API)
Any component that is intended to furnish pharmacologic activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals
batch
A specific quantity of a drug of uniform specified quality manufacturing order during the same cycle of manufacture
batchwise control
The use of validated in-process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned
certification
Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable
compliance
Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices
drug product
A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo
inactive ingredient
Any component other than the active ingredients in a drug product
lot
A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number
lot number, control number, or batch number
Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding, and distribution of a batch or lot of a drug product may be determined
master record
Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product
quality assurance
Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adquately
component
Any ingredient used in the manufacture of a drug product, including those that many not be present in the finished product
quality audit
A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality
quality control
The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference
quality control unit
An organizational element designated by a firm to be responsible for the duties relating to quality control
quarantine
An area that is marked, designated, or set aside for the holding of incoming components prior to acceptance testing and qualification for use
representative sample
A sample that accurately portrays the whole
reprocessing
The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process
strength
The concentration of the drug substance per unit dose or volume
verified
Signed by a second individual or recorded by automated equipment
validation
Documented evidence that a system (i.e. equipment, software, controls) does what it purports to do
process validation
Documented evidence that a process (i.e. sterilization) does what it purports to do
validation protocol
A prospective experimental plan to produce documented evidence that the system has been validated
quality control unit
Any person or organizational element designated by the firm to be responsible for the duties relating to quality control
theoretical yield
Quantity that would be produced at any appropriate phase of manufacture, in the absence of any loss or error
actual yield
Quantity that is actually produced at any appropriate phase of manufacture
