503B VALIDATION
cGMP COMPLIANT SERVICES
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STERILIZATION AND DEPYROGENATION CYCLE VALIDATION
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EQUIPMENT QUALIFICATION
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ASEPTIC PROCESS VALIDATION
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ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION (EMPQ)
ALL CQV Services > 503B validation services
503B VALIDATION
cGMP COMPLIANT SERVICES
Quantus provides experts in the field of Commissioning, Qualification, and Validation (CQV) services to help our 503B Pharmacy Customers comply to cGMPs, related to Commissioning and Qualifying new facilities, renovations, utilities, and equipment. Our Project Managers oversee and coordinate all the activities required to validate your facility and equipment to ensure compliance to cGMP Standards and Regulation.
All technical services are performed by Quantus Full Time Salaried Professionals. Quantus coordinates with alliance partners for some aspects of the startup phase depending on the specialized nature of the project
STARTUP COMMISSIONING
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DESIGN REQUIREMENTS REVIEW
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FACTORY ACCEPTANCE TEST (FAT)
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RECEIVING TURNOVER INSPECTION
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SITE ACCEPTANCE TEST (SAT)
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COMMISSIONING CHECKLIST
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PUNCHLIST ENFORCEMENT
QUALIFICATION & VALIDATION
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USER REQUIREMENTS REVIEW
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VALIDATION MASTER PLAN DRAFTING
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STERILIZATION AND DEPYROGENATION CYCLE VALIDATION
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EQUIPMENT QUALIFICATION
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ASEPTIC PROCESS VALIDATION
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ENVIRONMENTAL MONITORING PERFORMANCE QUALIFICATION (EMPQ)