It is important to ensure that a reserve sample representative of each lot or batch […]
Frequently Asked Questions
Our mission is to provide our clients with the knowledge necessary to be compliant with FDA’s most recent cGMP expectations thus enabling the production of the highest quality pharmaceutical and medical devices in the world. Below are some of our most frequently asked questions. If you have a question that is not answered below, please contact us and our team will do our best to answer.
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The Bi-Monthly Trends Report
Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.
According to the Code of Federal Regulations (CFR) section 21 CFR 820.50 Purchasing Controls each […]
Manufacturing quality products requires using raw materials that meet your quality standards. According to the […]