Our Regulatory Experts Can Help
Let our experts conduct a Gap Analysis / Audit of your facility to determine compliance with compounding regulations and standards. Our audit will identify areas where your operation needs improvement in order to achieve compliance.
Take the guesswork out of USP <795>, <797>, and <800> compliance. Be prepared for regulatory inspections.
What Is A Gap Analysis?
A Gap Analysis is a complete audit of systems and documents that according to industry regulations should be in use at your facility. For compounding pharmacies, this audit will also highlight gaps that may result in disqualification from 503A exemption status.
What Are the Results?
Our experts will provide you with a comprehensive report detailing the areas in your operation that need attention. Identified areas of improvement are considered “gaps” and should be proactively addressed and corrected to ensure compliance.
Our experts will assess equipment, personnel, and procedures and identify all areas that need to be corrected in order to meet the requirements of USP <795>, <797>, and <800>. See a complete list of what’s included below.
503A or 503B....Not Sure Where You Fall?
You’re not alone. Many pharmacies are unsure about FDA’s expectations including 503A exemptions & Insanitary Guidelines.
Maintain 503A Exemption Status
A small compounding pharmacy will be considered a pharmaceutical manufacturer if it falls short of just one of the conditions for exemptions outlined in section 503A of the Food Drug & Cosmetic Act. This means regulators will evaluate a pharmacy against the same CGMP requirements that large pharmaceuticals must abide by to stay in business.
Our consultants will help you navigate the nuances of these and other regulations so you can be confident of where your pharmacy stands.
An Inspection Before the Inspection
When you schedule your audit, an Eagle consultant will come and spend 2 to 3 days at your facility working with you to improve the quality of your operation and to ensure your processes are in line with regulatory expectations. Our mock FDA inspection allows you to make corrections ahead of time so that you’ll feel confident in the event of an inspection.
Our consultants have over 250 years of combined experience in compounding and GMP compliance. We’re among the most knowledgeable experts in the science and regulations that govern the compounding industry.
Hundreds of Satisfied Eagle Customers
My team and I have developed a great partnership with Eagle and their dedication to helping us with testing and consulting exceeds every expectation. Their consultants spend a lot time getting to know our company and what we need, while making it very personable. If you are looking for testing or consulting, Eagle is who to go to
My experience with Eagle has been nothing short of exceptional! Their professionals have years of experience and are very knowledgeable about the industry. I am especially impressed with the high level advice from Ross and the consulting team, as well as their guidance relating to organizational compliance and business growth. I highly recommend Eagle for any of your testing or consulting needs!
Pricing & Information
Make a one-time investment with long term benefits. Our team is committed to helping you achieve your compliance goals in a cost-effective and timely manner.
GAP Analysis Audit(Pricing below does not include expenses)
- 2-3 day audit assessing:
- Environmental Monitoring
- Aseptic Processing and Technique
- Documentation System
- Training Records
- Process Control
- Finished Preparations Testing
- Quality Assurance Program
GAP Analysis + Implementation Service
- Complete development of your customized Standard Operating Procedure (SOP) Manual
- Complete set-up of your environmental monitoring program
- Training on proper aseptic practices including proper gowning and gloving techniques