503A & 503B Compounders

RCA can strategically prepare your company by establishing a robust quality system designed in accordance with FDA and State Board of Pharmacy regulations.

• CGMP GAP analysis
• FDA 6 System Inspection.
• Policy and SOP drafting and review
• Aseptic processing controls and technique
• EMPQ, environmental and personnel monitoring
• Cleanroom certification – media fills, smoke studies
• Facility design and cross contamination controls
• Process and Cleaning validation
• Batch record review, data integrity and GDP
• CGMP team training
• Expansion of 503A facility to 503B Outsourcing Facility

RCA provides tailored services for Inspection Readiness, FDA 483 responses, FDA Warning Letter responses, CGMP training and compliance support for the State Board of Pharmacy and FDA.

• Responses for FDA 483s and Recalls
• Warning letters and consent decrees
• Deviation, investigations, and CAPA
• Third Party Oversight and qualification
• Shop floor quality oversite