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About Michael Anisfeld
Expertise
Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
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Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
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You are here: Experts > Health/Fitness > Pharmacology > Pharmaceuticals > Raw Material Sampling
Expert: Michael Anisfeld - 10/15/2009
Question
Is there any guideline which cites the quantity for Raw material sampling?
Or from where this root n+1 quantity was derived for raw material sampling?
Answer
You are asking two different questions.
For chemicals you need to sample sufficient material to perform each test (plus extra in case of an OOS), plus sufficient to keep for 2x testing of retained samples.
For packaging materials, use the ISO 2859 Sampling Tables to determine the number of samples to take (it is based on the incoming material batch size). If for example you receive 10,000 labels, from the ISO 2859 sampling table you will find that you need to sample 325 labels.
If the 10,000 labels came in 10 boxes (of 1,000 each), then the "root n+1" kicks in, and you need to take the 325 samples from 4 of the boxes (root 10+1), or 81 labels from each box.
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