Page 9 - Quality control of pharmaceuticals (07-PA 704)

4. the type and condition of sample container to be used.
5. any special precautions to be observed, especially with regard to the

sampling of sterile materials.
6. the storage conditions.

Glossary & Definitions
Sampler

Person responsible for performing the sampling operations.
Sampling plan

Description of the location, number of units and/or quantity material
that should be collected, and associated acceptance criteria.

Sampling record
The sampling record should contain the 1)batch number, 2) date and 3)

place of sampling, 4) sampling protocol used, a 5) description of the
containers and of the materials sampled, 6) notes on possible
abnormalities and the 7) name and signature of the inspector.

For Which Purpose?
Routine batch release by QC laboratory at manufacturing site.
Routine market surveillance testing (post-marketing surveillance).
Suspicion of inferior quality / safety or efficacy issue:
Suspicion of deterioration; product suspected to be responsible for

adverse clinical reactions or ineffective.