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Gap Analysis Audit

CLOSE THE GAPS IN YOUR COMPOUNDING FACILITY

Know where your pharmacy needs attention in all matters of compliance including quality, equipment, processes and procedures, environmental monitoring, and more.

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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. 

What's Included?

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.

 

An illustration of a man wearing a suit holding a clipboard while facing a small building with a "compounding pharmacy" sign. Thought bubble above the man has a large skyscraper labeled pharmaceutical manufacturer

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. 

Consulting Team

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.

David-Hussong

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

Saad Dino

Owner, Acton Pharmacy

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!

Emil Haldey

Owner, Haldey Pharmaceutical Compounding

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 Interest Form


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