PRELIM 02 - Concepts in Pharmaceutical Quality Assurance Flashcards
Refers to the action of proving that any procedure, process, equipment, material, activity, or system actually and consistently leads to the expected results
Validation
This team’s responsibility is to identify needs, develop protocols, and conduct validation/qualification
Validation team
Is a high-level document that establishes an umbrella validation plan for the entire product
Validation master plan (VMP)
Refers to the process of establishing documented evidence that a process used in manufacture does what it purports to do
Prospective validation
Refers to validation carried during routine production of products intended for sale
Concurrent validation
Refers to validation of a process for a product that has been marketed based upon accumulated manufacturing
Retrospective validation
Refers to repeated validation of an approved process to ensure continued compliance with established requirements
Revalidation
Refers to the action of proving and documenting that premises, systems, and equipment are properly installed
Qualification
Validation that demonstrates that an analytical procedure is suitable for its intended purpose
Analytical method validation
The ability to assess unequivocally the analyte in the presence of components which may be expected to be present
Specificity
The ability to obtain test results which are directly proportional to the concentration of analyte in the sample
Linearity
The interval between the upper and lower concentration of analyte in the sample
Range
Expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value
Accuracy/Trueness
Expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogenous sample
Precision
Expresses the precision under the same operating conditions over a short interval of time
Repeatability/Intra-assay precision
Expresses within-laboratories variations: different days, different analysts, different equipment, etc.
Intermediate precision
Expresses the precision between laboratories (collaborative studies, usually applied to standardization of methodology)
Reproducibility
A limit that refers to the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value
Detection limit
A measure of the capacity to remain unaffected by small, but deliberate variations in method parameters
Robustness
Type of testing based on the concept that the equipment, electronics, analytical operations and samples to be analyzed constitute an integral system that can be evaluated as such
System suitability testing
Refers to the actions taken to remove a product from the market
Product recall
An NSAID and a prescription painkiller that was recalled in 2004 due to risk of deadly heart attacks
Rofecoxib (Vioxx)
An alert issued within 24 hours after the FDA director general approves a product recall order
Public health alert
Situation in which there is a reasonable probability that the use or exposure to the product will cause serious adverse health consequences or death (Recall classification)
Class 1
Situation in which use or exposure to the product may cause temporary or medically reversible adverse health consequences (Recall classification)
Class 2
Situation in which use or exposure to the product is not likely to cause adverse health consequences (Recall classification)
Class 3
Refers to the ability to discover or determine the existence, presence, or fact of a hazard
Detectability
Refers to damage to health, including the damage that can occur from loss of product quality or availability
Harm
Refers to the potential source of harm
Hazard
Refers to all phases in the life of the product from the initial development through marketing until the product’s discontinuation
Product lifecycle
Refers to the degree to which a set of inherent properties of a product, system, or process fulfills requirements
Quality
Refers to the combination of the probability of occurrence of harm and the severity of that harm
Risk
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle
Quality risk management
The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met
Quality system
Assessment that consists of the process of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards
Risk assessment
Refers to the systematic use of information to identify hazards referring to the risk question or problem description
Risk identification
Refers to the estimation of the risk associated with the identified hazard
Risk analysis
An evaluation that compares the identified and analyzed risk against given risk criteria
Risk evaluation
Refers to the decision making to reduce and/or to accept risks
Risk control
Reduction that focuses on the process for mitigation or avoidance of quality risk when it exceeds a specified level
Risk reduction
Refers to a decision to accept risk; can be a formal or passive decision
Risk acceptance
Refers to the sharing of information about risk and risk management between the decision makers and other parties
Risk communication
Refers to reviewing outputs/results of the risk management process
Risk review
Meaning of FMEA
Failure mode effects analysis
Meaning of FMECA
Failure mode, effects, and criticality analysis
Meaning of FTA
Fault tree analysis
Meaning of HACCP
Hazard analysis and critical control points
Meaning of HAZOP
Hazard operability analysis
Meaning of PHA
Preliminary hazard analysis
Refers to a systematic analysis of potential failure modes aimed at preventing failures
Failure mode and effect analysis
A number that is simply calculated by multiplying the severity rating, times the occurrence probability rating, times the detection probability rating of all the items
Risk priority number (RPN)
Refers to the ability of a drug to retain its chemical, physical, microbiological, and biopharmaceutical properties within specified limits throughout its shelf-life
Stability
The period of time during which a drug product is expected, if stored correctly, to remain within specification as determined by stability studies on a number of batches of the product
Shelf life/Expiration dating period/Validity period
Refers to a series of tests designed to obtain information on the stability of a pharmaceutical product
Stability tests
Refers to the date indicating the completion date of the manufacture of a batch
Date of manufacture
Refers to the date placed on the container of a drug product that designates the date up to and including which the product is expected to remain within specification if stored correctly
Expiration date
Refers to the period of time for which the API remains within specification when stored under the recommended conditions in the proposed bulk storage container
Re-test period
Refers to the shelf-life determined by projecting results from accelerated stability studies
Provisional shelf-life
Refers to the period of time during which a reconstituted preparation or the finished dosage form in an opened multidose container can be used
Utilization period
Type of testing that establishes the “period of time during which a multidose product can be used while retaining quality within an accepted specification once the container is opened”
In-use stability testing
Refers to conditions that involve storage in dry, well-ventilated premises at temperatures of 15-25°C, or depending on climatic conditions, up to 30°C
Normal storage conditions
Type of testing designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions
Accelerated stability testing
Studies on the physical, chemical, biological, biopharmaceutical, and microbiological characteristics of a drug, during and beyond the expected shelf-life
Shelf-life stability studies
Refers to a list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical in limits, ranges, or other criteria for the tests described
Specifications
Refers to the specifications that determine the suitability of a drug substance throughout its retest period
Re-test specifications
Refers to the specifications that determine the suitability of a drug product at the time of its release
Release specifications
Stability tests are performed to provide a means of comparing alternative formulations (Phases of development)
Product development phase
The drug regulatory authority will require the manufacturer to submit information on the stability of the product (Phases of development)
Registration phase
The manufacturer carries out on-going real-time stability studies to substantiate the expiry date and the storage conditions previously projected (Phases of development)
Post-registration phase
Each active ingredient retains its chemical integrity and labeled potency within the specified limits (Type of stability)
Chemical stability
The original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained (Type of stability)
Physical stability
Sterility or resistance to microbial growth is retained according to the specified requirements (Type of stability)
Microbiological stability
The therapeutic effect remains unchanged (Type of stability)
Therapeutic stability
No significant increase in toxicity occurs (Type of stability)
Toxicological stability
Temperate (International climactic zone)
Zone I
Subtropical, with possible high humidity (International climactic zone)
Zone II
Hot/dry (International climactic zone)
Zone III
Hot/humid (International climactic zone)
Zone IV
ASEAN nations & Brazil have adopted __________°C & __________% RH
30°C & 75% RH
A design in which only the extremes are tested at all time points (Types of reduced study designs)
Bracketing
A design in which a selected subset of samples is tested (Types of reduced study designs)
Matrixing
Refers to the lowest amount of analyte in a sample which can be quantitatively determined with suitable precision and accuracy
Quantitation limit
