(Prelim) Introduction to Quality Control [Pharm Ana 1 LEC] Flashcards
QUALITY
Degree of excellence (Webster’s Dictionary)
QUALITY
Sum of all factors which contribute directly or
indirectly to the safety, effectiveness, and
reliability of the product
QUALITY
“Doing it right the first time and all the time”.
(TQM)
QUALITY
Excellence that is better than a minimum standard
QUALITY
Drug quality is our main business.
QUALITY
Reality: Poor quality drugs do not meet official
standards for:
○ Strength
○ Quality
○ Purity
○ Packaging
○ Labelling
Poor quality drugs do not meet official
standards for:
○ Strength
○ Quality
○ Purity
○ Packaging
○ Labelling
DRUG QUALITY IN THE WORLD…
Availability of substandard and counterfeit drugs in disturbing proportion in many low-income countries
DRUG QUALITY IN THE WORLD…
Lack of reliable drug quality assurance systems in many developing countries
IMPLICATIONS
● Treatment failure
● Adverse effects
● Increased morbidity
● Mortality
● Development of drug resistance
● Wasted resources
2 types of Quality
- Quality Assurance
- Quality Control
QUALITY CONTROL (QC)
The sum of all tests performed to determine the conformance of the product to specification
ROUTINE of Quality Control
- RM and Analysis
- Intermediate stage analysis
- Finished Product Analysis
- Stability Studies
Quality Control
- Guarantees that the product:
○ Is free of impurities
○ Physically and chemically stable
○ Contains the amount of active
ingredients as stated in the label
○ Provides optimal release of active
ingredients when the product is
administered
NON- ROUTINE of Quality Control
- Calibration & Preventive maintenance of instruments
- Preparation of reference/ working standards
- Method development and Validation
Quality Assurance
Over-all organizational body designed to assure product quality
Quality Assurance
Sum of all processes performed to ensure that
the product possess all the characteristics it is
intended to have
FOCUS QA
To prevent defects with a focus on process
FOCUS QC
To identify defects after in the product
GOAL QA
To improve development and test processes so that defects do not arise
GOAL QC
To identify defects after a product is developed and before it is released.
How QA
Establish a good QMS and assessment of its adequacy with continuous monitoring