The FDA conducts all establishment inspections based upon a systems approach. The FDA's Quality Systems Inspection Technique (QSIT) covers Quality, Facilities/Equipment, Materials, Production, Packaging/Labeling, and Laboratory. Compliance Insight conducts audits following this model so that our clients are fully prepared. We can conduct full inspections encompassing all six areas as well as abbreviated inspections which focus on selected area(s).
Pre-Approval Inspections (PAI) Preparation Audits
You've worked long and hard to get your product reviewed and approved by the FDA. Don't let the pre-approval inspection delay the launch of your new product. Let us help you prepare by conducting an audit before the FDA does. We can identify potential problems and deficiencies that you can be prepared to respond effectively to the FDA inspectors.
Vendor/Contract Mfg Audits
Most industries rely on outside vendors and suppliers for raw materials, components or services. The quality of your product depends on their compliance as well as yours. We can audit your outside vendors or contract manufacturers to determine their level of compliance so that you can make prudent business decisions and maintain your level of compliance and commitment to quality.
General Assessment - verify that you are in compliance with federal regulations
GMP Gap Analysis - evaluate where you are and where you should be
Full Audit
Our Full Audit Service utilizes a 5-step approach which begins with anauditwhich assesses your level of compliance and uncovers gaps in your existing program. We then help you develop an implementation plan to resolve issues and make the changes needed to bring you into compliance with federal regulations. We can help you with execution of the plan by providing training, SOP development, batch record review, and validation assistance.Finally, we can verify your progress with a follow-up audit.
Due Diligence
We can be part of your team to evaluate the compliance status of any firm that you are interested in purchasing. Our due diligence services include an evaluation of the following areas:
Quality Assurance
Regulatory Affairs
Stability
Laboratory Operations
FDA Compliance
Operational Quality
Facility Compliance
We will provide you with a report of our findings - both good and bad.
Contact Us
Call us at 513-860-3512 to discuss how we may be of service to you, or email us at info@compliance-insight.com with questions.
Compliance Insight, Inc. 513-860-3512 Copyrighted 2001 - 2011, Compliance Insight, Inc.
