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Expertise on GMPs, Testing and Documentation

<p>NSF International responds to common questions about running a legal, safe natural product manufacturing facility.</p>

NSF International provides high-quality training on a variety of dietary supplement good manufacturing practice (GMP) topics instrumental to understanding regulations and critical to achieving or maintaining regulatory compliance. During these trainings, NSF commonly receives questions related to GMP compliance, such as testing, expiration dates and documentation. NSF gathered these questions for this “Ask the Expert" Report, and provides the responses.

In the Report, NSF answers the following questions:

1.            What testing do we have to do if we are a distribution center for dietary supplements only?

2.            What testing do we have to do if we package and label material?

4.            Is a ‘Best By’ or ‘Use By’ date considered an expiration date?

5.            Do we have to give FDA our original documents/records or copies?

6.            What are the top three findings typically written up by NSF during dietary supplement audits?

7.            Regarding supplier qualification, do we really have to confirm the supplier certificate of analysis (CoA) by testing the entire CoA for three different lots? We only test against our specs so should that be sufficient?

8.            Are we obliged to qualify all of our suppliers?

9.            For multi-active ingredients on the label claim, how much potency testing is required to be compliant?

10.          Do we have to test incoming packaging components (for example bottles) for microbial contamination?

Download the Report to get NSF’s response.

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