stability studies qc 2 midterm

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 )