The Auditing Group
GMP - GCP - FDA, EMA, ISO & Vendor Audit & Remediation
U.S. Headquarters - In-Country China, India & South America GMP/GLP/GCP Auditors for Suppliers, CMOs and 'For-Cause' Audits!
01-856-437-5880
1, 2, or 3 day Onsite Turnkey Audits starting at $5,995!
Factory Capability & Capacity Audit
(FCCA Audits)
Does your CMO or Facility have the Capabilities to support your requirements,
or the Capacity of existing operations to support your needs?
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Basic GMP QMS QSR ISO Concepts and Practices
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Review of current Quality Management System practices, programs and policies
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Standard Operating Procedures, Work Instructions, Policies and Practices
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Device Master Record (DMR)
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Device History Records (DHR) or Assembly Records
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Design History File (DHF)
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Interviews with key staff
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Quality Assurance Process and Practice Reviews
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Quality Manual / Quality Management System Review
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CV Review, Job descriptions, Organizational charts, Roles and Responsibilities
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Training records, curriculums and Training programs
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Quality Control Program
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Internal Audit Procedures and Reports
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Vendor/Supplier Qualification/Inspections/Audits
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Document Control and Management Processes
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Past / Previous Audit Reports (3rd Party/Internal/Agency)
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Network Infrastructure and Systems Management/Security Procedures
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Facilities including physical inspections
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Engineering, Maintenance, Metrology, Janitorial and Facilities
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Equipment/Instrumentation; Qualification/Validation/Calibration/Maintenance
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Asset Management
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Site Qualifications/Facility Qualifications, Basis of Designs (BOD) and Site Master Plans.
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Asset Management
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Site Qualifications/Facility Qualifications, Basis of Designs (BOD) and Site Master Plans.
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Change/Process Controls
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Quality Technical Agreements
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Corrective and Preventative action programs (CAPA, Facilities and Systems)
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Non-Conformance, Out of Specifications Practices
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Deviation reports/QA reports
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Batch Records/Production Record Review (Masters and In-Process)
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Report preparation/review/approval/revision
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Document Control / Document Management
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Archival system and Record retention program
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Process/Equipment/Facility/Systems Validation and Qualification
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Methods Development, Transfer Validation
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Preparation and Tracking of Standards
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Accuracy and Precision of Data Entry Qualifications
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Tracking Analytical Results and Compliance (GLP Audits)
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Acceptance and Rejection Criteria
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Retest/Repeat Analysis
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Test and Control Article Chain of Custody (GLP/Clinical)
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Water System, Waste Systems and Facility Utility Qualification/Validation
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Environmental Systems Monitoring / Building Monitoring Systems
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Specimen/Sample/Collection Receipt/Identification/Handling/Documentation (GLP/GCP)
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Data collection/verification/management (GLP/GMP and GCP)
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Computerized Systems in support of GxP activities
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21 CFR Part 11 Compliance
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Computer Systems Validation and Qualification