Custom SOP Package
Microtest’s complete sets of customized standard operating procedures (SOPs) are among the compliance deliverables most requested by Pharmacy Directors. USP 797 requires that sterile drug compounding pharmacies maintain these documents in writing for all relevant operational compounding procedures.
 Some pharmacies have elected to purchase “brown bag” documents from other vendors, or download generic formats available on the Internet. But these seldom meet the expectations of USP 797 auditors. U.S. federal agencies demand that such documentation be specific and in general use in any given sterile drug compounding pharmacy service.
Microtest develops client-specific standard operating procedures for USP 797 compliance activities to supplement pharmacy service existing quality assurance (QA) program. It’s just part of our total compliance solution.
These comprehensive SOP packages, written and approved, are prepared by our highly qualified microbiologists and compliance experts. They draw on extensive experience working with industry, hospitals, and regulators in both microbiological testing and sterile drug compounding. All documents are customized to the specific layout, equipment, personnel, and actual, day-to-day procedures of the individual pharmacy service.
When there is limited time, experience, or expertise necessary to write and maintain all these documents, Microtest is the solution! We provide the top-quality documentation you need for the following categories:
- Sterile drug compounding
- Cleaning
- Gowning/contamination control
- Equipment maintenance and operations
- Employee training
- Environmental monitoring
- Clean room operations
- And more
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