Page 12 - Quality control of pharmaceuticals (07-PA 704)
P. 12
Failure to do will give results that are an incorrect representation of the
original material.
The specific approach you use to acquire a sample is known as the
sampling plan
Sampling operations should be supervised and documented => sample
collection form => always kept together with the collected sample.
Sample collection form (Sampling record): written record of the
sampling operations.
Store the sample in a properly labelled container: sample type, name of
material, batch number, quantity, date of sampling, storage
conditions, handling precautions, container number....
Containers
Containers used to store a sample should comply with the storage
directions for the active pharmaceutical ingredient, excipient or drug
product:
should not interact with the sampled material.
should not allow contamination.
should protect the sample from light, air and moisture.
should be sealed and adequately labelled.
transported in such way as to avoid breakage.
