Good Manufacturing Practices (GMP)

Good Manufacturing Practices – Guaranteeing Strict Confidence and Adherence to the Highest Quality Standards

Experienced and trusted, ClinAudits consultants understand the drug development process so they can guide your projects through the audit process. They can report directly to a representative within your organization so that you maintain control that is crucial to managing security and business risks.

With a commitment to providing cost effective, secure and timely results, ClinAudits offers resources to augment your internal staff and enhance their productivity.

  • GMP Compliance Auditing:
    • GMP facility audit to FDA, DEA, ISO, ICH and other governmental authority requirements

  • Internal audit system development:
    • Evaluation of sponsor and contract manufacturing supply operations
    • QA/QC system evaluations
    • Product complaint investigations
    • Labeling
    • Storage and distribution
    • GMP record and report requirements
    • FDA, MHRA and EMA inspection readiness

  • Regulatory agency audit response formulation and remediation:
    (PMA, PAI, 483, Consent Decree, Recalls, Warning Letters and Market withdrawals, etc.)
  • Quality systems assessment, risk, assessment, design and implementation; Needs/Gap analysis
  • Process and scale-up validation
  • Equipment/Process Qualification/Validation of manufacturing equipment, product process and
    equipment cleaning
  • Computer validation
  • Environmental monitoring
  • Review method validation (analytical and microbiological)
  • Review Vendor Certification Programs
  • Evaluation of GMP compliance for Phase 1 units for preparation and labeling of IMPs
  • Clinical trial supplies service provider audits
  • Utility and facility design and monitoring
  • Management strategies for compliance systems
  • Training of employees to GMP’s; Beginner, Intermediate, Advanced levels; Group or individual
  • Quality systems integration and harmonization: For difficult, combination products and/or multiple quality systems requirements
  • Vendor and supplier audits – GMP vendor qualification
  • Documentation and batch record systems development
  • Review and development of SOP’s
  • 21 CFR Part 11 compliance
  • GMP clinical trial supplies materials, labeling, review suppliers (raw materials, packaging,
    labeling components, distribution of clinical trial materials)
  • Inspect facilities, equipment and laboratories
  • Assess CAPA programs/ Deviation systems development/CAPA effectiveness
  • Stability Program implementation
  • Mock FDA/EMA/MHRA auditing- inspection readiness/pre-approval GMP inspection audits
  • Recall, Adverse Event and Complaint systems implementation

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