A quality-assured medicine is a medical product that has been evaluated or controlled through appropriate quality systems to ensure that it meets established standards for identity, strength, purity, quality, and performance.
Quality assurance involves more than checking a medicine after it has been manufactured. It encompasses systems and controls intended to ensure that medicines consistently meet appropriate standards throughout their production and supply.
Quality assurance can involve manufacturing standards, testing, regulatory oversight, appropriate storage and distribution, and other controls designed to protect the quality of the medicine.
For patients, quality-assured does not mean that a medicine is guaranteed to work for every individual. It means that the product meets the required quality standards and is what it is supposed to be.
QUICK FACT
Medicine quality and treatment effectiveness are related but not identical. A quality-assured medicine can still be the wrong treatment for a particular illness.
COMMONLY CONFUSED WITH
- Falsified medicine — A product deliberately misrepresented as something it is not.
- Substandard medicine — An authorized product that fails to meet required quality specifications.
- Effective medicine — A medicine that produces the intended clinical effect; quality assurance does not guarantee effectiveness in every patient or situation.
SEE ALSO
- Falsified medicine
- Substandard medicine
- Medicine authentication
- Antimicrobial resistance
