Pharmaceutics Exam 1
A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture Correct answer- Batch
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 Correct answer- Batchwise control
Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable Correct answer- Certification
Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices Correct answer- Compliance
Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product Correct answer- Component
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 Correct answer- Drug product
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 Correct answer- Active ingredient or active pharmaceutical ingredient (API)
Any component other than the active ingredients in a drug product Correct answer- Inactive ingredient
A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number Correct answer- Lot 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 Correct answer- Lot number, control number, or batch number
Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product Correct answer- Master record
Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately Correct answer- Quality assurance
A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality Correct answer- Quality audit
The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference Correct answer- Quality control
An organizational element designated by a firm to be responsible for the duties relating to quality control Correct answer- Quality control unit
An area that is marked, designated, or set aside for the holding of incoming components
prior to acceptance testing and qualification for use Correct answer- Quarantine
A sample that accurately portrays the whole Correct answer- Representative sample
The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process Correct answer- Reprocessing
The concentration of the drug substance per unit dose or volume Correct answer- Strength
Signed by a second individual or recorded by automated equipment Correct answer- Verified
Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do Correct answer- Validation
A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture Correct answer- Batch
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 Correct answer- Batchwise control
Documented testimony by qualified authorities that a system qualification, calibration, validation, or revalidation has been performed appropriately and that the results are acceptable Correct answer- Certification
Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards, and practices Correct answer- Compliance
Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product Correct answer- Component
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 Correct answer- Drug product
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 Correct answer- Active ingredient or active pharmaceutical ingredient (API)
Any component other than the active ingredients in a drug product Correct answer- Inactive ingredient
A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number Correct answer- Lot 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 Correct answer- Lot number, control number, or batch number
Record containing the formulation, specifications, manufacturing procedures, quality assurance requirements, and labeling of a finished product Correct answer- Master record
Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately Correct answer- Quality assurance
A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality Correct answer- Quality audit
The regulatory process through which industry measures actual quality performance, compares it with standards, and acts on the difference Correct answer- Quality control
An organizational element designated by a firm to be responsible for the duties relating to quality control Correct answer- Quality control unit
An area that is marked, designated, or set aside for the holding of incoming components
prior to acceptance testing and qualification for use Correct answer- Quarantine
A sample that accurately portrays the whole Correct answer- Representative sample
The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process Correct answer- Reprocessing
The concentration of the drug substance per unit dose or volume Correct answer- Strength
Signed by a second individual or recorded by automated equipment Correct answer- Verified
Documented evidence that a system (e.g., equipment, software, controls) does what it purports to do Correct answer- Validation
