ICH guideline Q1A(R2), states that “the purpose of stability testing is to provide evidence on […]
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.
Line clearance is an integral part of every facility’s standard operating procedure in order to […]
According to the Code of Federal Regulations (21 CFR 211.42 Design and Construction Features), any […]