​Our auditors’ in-depth knowledge of domestic and international regulations, and their hands-on GMP experience, can take the uncertainty out of GMP compliance (e.g., 21 CFR Part 111).
 
Polaris performs the following onsite and remote GMP activities:

• Facility Audits, including manufacturing, warehouses, QC Laboratories
• Vendor GMP Audits
• IQ/OQ/PQ Audits and Documentation
• Oversight of contract services, including CDMOs
• GMP Clinical Trial Materials
• Inspection Readiness/Pre-approval GMP Inspection Audits
• GMP Quality Systems
• GMP Validation
• Batch Record Review
• PAI readiness

 
If deficiencies are identified, Polaris can make recommendations on how to develop a CAPA plan to become compliant, assist you with implementing your plan, and prepare you for an FDA inspection.
 
Polaris’ experienced CGMP management can also help you interface with the district FDA office regarding quality compliance issues.

Compliance & quality consulting for your business success

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