qc lec stability studies

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