FDA Inspection Audit Support
GxP Audits / Remote or Onsite / Inspection Readiness / Mock FDA Audit / GAP Analysis / Validation
A Proactive Quality Management System
Surviving an FDA inspection is all about managing risk and knowing what is important to the FDA.
Premier FDA Solutions knows the importance of fostering a culture of quality as the FDA is continuing to prioritize a Proactive Quality Management System. Recognizing this and also knowing that every company’s needs are unique, we have a range of right-sized FDA audit support services to meet your needs, whether you are in need of a comprehensive corporate quality management system audit or a focused site audit. Our thorough, attentive FDA audit support services help you reduce FDA inspection risks while you continue to focus on your business objectives.
GxP Audit Support
The preparation you need for a successful FDA audit
Validation / Qualification Activities:
- Evaluate the adequacy of products, equipment, and facilities
- Validation/qualification of policies, procedures, protocols, and master plans
- Validating/qualifying electronic records; manufacturing, packaging, and labeling processes; cleaning, sterilization systems and processes; and facilities, utilities, and equipment
- Computer Systems Validation and 21CFR Part 11 Compliance
Other Inspection Related Activities:
- Internal audits or GAP assessments of the Quality Management System
- Vendor and Supplier audits
- GDP audits
- Due Diligence
Audits Include the Following Customizable Components
- A pre-audit kickoff call outlining client objectives and daily agenda for the audit, including customized audit approach:
- Formal FDA Audit, “Hats-on, Hats-off” Audit, deep dive into specific area, high level “checkup”, etc.
- Onsite or remote audit with guidance before and during the inspection
- An initial summary of the overall audit findings at the close of the onsite visit
- A detailed, written audit report outlining Observations & Deficiencies (categorizing by criticality)
- A risk-based Corrective Action Plan (Premier FDA Solutions can also assist with any needed post-audit remediation of documents and Quality System GAPs.)