Page 4 - Quality control of pharmaceuticals (07-PA 704)

Quality Assurance & Quality Control

Quality: means distinction, or excellence, or high degree of superiority.
Quality of “product” or “service”:
Free from deficiency.
Meet requirements of stated needs.

Quality of “Drug Product” (Medicinal Product):

Means that the product is safe and effective(meets the requirements)
2. Features and characteristics of the product meet the requirements of
intended use:
Identity: make sure that the active ingredient is present.
Purity: make sure that the product is free from harmful impurities.
Potency: the product contains 100 ± 10 % of active ingredient and the

variation in drug level in individual dosage forms should be
minimum.
Stability: the medicine should be stable until the expiry time stated on the
label (shelf life time).
Uniformity: the size, shape and color should be consistent.
Bioavailability (Therapeutic Effect): it is the speed and completeness by
which the drug enters the blood stream.