Page 8 - Quality control of pharmaceuticals (07-PA 704)

Glossary & Definitions
Sample
What is a Sample?

A portion, piece, or segment that is representative of a whole.
In the context of medicines “a portion / piece / segment” means:
x g/mL active pharmaceutical ingredient / excipient / bulk material… or
x units of the finished dosage form (tablet, bottle,…) representative of a

batch.

Glossary & Definitions
Sampling
The act, process, or technique of selecting an appropriate sample.
In the context of quality control of medicines “an appropriate sample”

means: representative sample to evaluate the quality of the whole
batch.
Glossary & Definitions
Sampling procedure
The sample taken should be done in accordance with approved written
procedures that describe:
1. the method of sampling
2. the equipment to be used
3. the amount of sample to be taken