If your browser does not accept cookies, you cannot view this site.There are many reasons why a cookie could not be set correctly.Over the last several years, inadequate validation has been one of the most common sources of US FDA Form 483 findings, so it is critical to address this requirement early.Responding to a FDA Form 483 from the US FDA is disruptive and expensive, but can be much more so if major changes are required to retroactively validate a process, system, piece of equipment or working environment.This can considerably reduce the costs associated with a validation.The experienced packaging engineers and microbiologists on staff at QTS can assist in establishing product families for validation and routine monitoring purposes.Regulatory authorities recognize the critical nature of a sterile barrier system.
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By establishing product families, QTS can help minimize testing costs.
We’ll help you through the process of justifying product family groupings, as well as selecting product family representatives.
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