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cGMP Compliance Consulting - Dietary Supplement/Food

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The cGMP compliance consulting will be conducted in accordance with FDA’s requirements (21 CFR Part 111 with its interpretations for dietary supplements and 21 CFR Part 110 for foods). We will support our clients in building an overall cGMP - compliant quality system in terms of hardware, software, and personnel. Our experienced consultants will conduct on-site consultation in conjunction with off-site document review.

Service

  • cGMP Compliance Audit on Quality System and Gap Analysis
    • General GMP audit
    • Special GMP audit (in particular aspect)
    • Audit on contractors
  • cGMP Compliance Review of Facility Design and Construction
    • Guide GMP requirements for facilities
    • Review design drawings
    • Audit on constructions
  • Validation System
    • Master validation plan and project plan
    • Design and review validation protocols
    • Review validation results and reports
  • Documentation System
    • Corporate level documents and master record
    • Management level documents
    • Operational level documents and batch record
  • Laboratory Control System
    • Raw material control tests
    • Product final release tests
    • Validation of analytical methods
    • Housekeeping and management of lab operations
  • Production and Process Control System
    • Equipment qualification and process validation
    • Environment and process monitoring
    • Calibration and maintenance
    • Batch records and SOPs
  • Quality Assurance System
    • Change control
    • GMP and SOP-based job function training
    • Batch record review
    • Deviation and investigations
    • OOS and investigations
  • Material Control System
    • Vendor evaluation and control
    • Material incoming, storage, and dispatching

Other Service

  • Mock FDA Routine Inspections
  • Response to FDA 483s
  • Response to FDA Warning Letters

Training

Link to "Services" for more information.