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The Challenge of complying with FDA's cGMP's in the Packaging Department
Author            :Nancy L. St. Laurent, CPP
Designation    :President
Company        :STL LINCS
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Synopsis

Packaging is packaging – right? Well for the most part that is correct. However, when you specify pharmaceutical packaging equipment, there are some significant differences. All companies have to comply with some regulations and some of these cross over all industries, such as OSHA, etc. But the pharmaceutical industry has to comply with FDA regulations. These are called current Good Manufacturing Procedures, cGMP’s. These require industry to install equipment that is compliant with these regulations. The equipment must also be validated, meaning it will operate the way it is intended to operate at all times. This article will outline how to specify, purchase, install and operate equipment to satisfy these regulations.

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