Page 10 - Quality control of pharmaceuticals (07-PA 704)
P. 10
Suspicion of adulteration.
Stability testing.
The materials to be sampled may belong to the following classes:
— Starting materials for use in the manufacture of finished
pharmaceutical products;
— Intermediates in the manufacturing process (in-process control)
(e.g., bulk granule);
— Pharmaceutical products (in-process as well as before and after
packaging);
— Packaging materials including “Patient Information Leaflet
(PIL), label etc.”; and
— Cleaning and sanitizing agents, compressed gases and other
processing agents.
Sampling Process
1. Preparation for sampling
2. Sampling collection
3. Sample storage
