GMP Storage & Distribution Audit Compliance

At InterlinkIQ, we understand the critical importance of adhering to Good Manufacturing Practices (GMP) in the storage and distribution of pharmaceuticals, biologics, and medical devices. Our GMP Storage & Distribution Audit Compliance services are designed to help organizations maintain the highest standards of quality, safety, and regulatory compliance. We partner with you to enhance your operations, mitigate risks, and ensure compliance with FDA regulations.

Comprehensive GMP Audits

  • Conduct thorough assessments of your storage and distribution facilities.
  • Evaluate compliance with 21 CFR Parts 210, 211, and 820.
  • Identify potential gaps and provide actionable recommendations for improvement.

Risk Assessment and Mitigation

  • Analyze your current processes to identify risks in storage and distribution.
  • Develop and implement risk mitigation strategies tailored to your operations.
  • Establish protocols for ongoing risk management.

Training and Education

  • Provide customized training programs for staff on GMP principles, regulatory requirements, and best practices.
  • Offer workshops and seminars to ensure all personnel understand their roles in maintaining compliance.

Documentation and Record-Keeping Support

  • Assist in developing and optimizing documentation processes for storage and distribution activities.
  • Ensure all records meet FDA requirements and are readily accessible for inspections.

Quality Management Systems (QMS) Implementation

  • Support the design and implementation of robust QMS tailored to your organization’s needs.
  • Facilitate continuous monitoring and improvement of your quality practices.

Transportation Compliance Consulting

  • Evaluate your transportation methods and conditions to ensure product integrity during transit.
  • Recommend solutions for temperature control and tracking during distribution.

Internal Audit Support

  • Provide guidance and tools for conducting effective internal audits.

    Assist in preparing for FDA inspections, including mock audits and compliance checklists.

Continuous Improvement Programs

  • Establish frameworks for ongoing evaluation and enhancement of your storage and distribution practices.

    Help you create a culture of compliance and quality within your organization.

Ensure the integrity of your products and the trust of your customers with InterlinkIQ's expert GMP Storage & Distribution Audit Compliance services.

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