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Development of a Strategic Relationship with Facilities-Maintenance/ Outside Contractors for Interaction with Controlled Environments

The following report is to discuss the concerns and complications along with the actions to take when dealing with controlled environment facility-related issues.  Pharmacy is responsible to demonstrate a continuous “State of Control” over their sterile compounding facility. General: Facility/maintenance staff must not work...

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LAFW Observations

What's wrong with this picture? The HEPA filter is stained with overspray from the compounding operation.  While there are no tests that a certifier will conduct that tend to demonstrate that this staining is problematic, the FDA has made it clear through their...

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