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cGMP COMPLIANCE
Cirrus is registered with the United States Food and Drug Administration as a cGMP-compliant facility. Compliance to cGMP regulations is maintained through a well-documented system including written SOPs and the following key programs:
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Employee training
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Equipment maintenance, calibration and validation
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Documentation
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Materials handling
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Change control
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Record retention
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Internal auditing
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QA/QC review of data
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Several of our clients have conducted audits of our facility and practices. All have found Cirrus to be in compliance of our regulatory controls. In 2003 and 2008, the FDA completed a general audit of Cirrus and found the facility and the practices to be compliant with 21 CFR Parts 210 and 211, with no observations.
At Cirrus Pharmaceuticals, all employees are committed to quality. This commitment has built client confidence resulting in continual growth of the company.
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