Close The Gaps In Your Facility
Let our experts conduct a Gap Analysis Audit of your facility to determine compliance with regulations and standards. Our audit will identify areas where your operation needs improvement in order to achieve compliance. Take the guesswork out of 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. We can assist you in determining the optimal layout of your space to maximize efficiency and workflow all while keeping growth in mind.
What Are The Results?
Our experts will provide you with a comprehensive report detailing the areas in your operations that need attention. Identified areas of improvement are considered “gaps” and should be proactively addressed and corrected to ensure compliance.
What Is Included?
Our experts will assess equipment, personnel, and procedures and identify all areas that need to be corrected in order to meet regulatory requirements. See a complete list of what is included below.
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.
GAP Analysis Audit†‡
A 2-3 day GAP Analysis Audit assessment is conducted. This assessment includes:
- Environmental Monitoring
- Aseptic Processing and Technique
- Documentation System
- Training Records
- Process Control
- Finished Preparations Testing
- Quality Assurance Program
GAP Analysis + Implementation Service†
The GAP Analysis Audit plus the implementation of service includes:
- 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.
† Custom quote required.
‡ Pricing does not include expenses.
Our consultants have decades of combined experience in compounding and CGMP compliance. We’re among the most knowledgeable experts in the science and regulations that govern the compounding industry.
GAP ANALYSIS INTEREST FORM
“I’m delighted to be doing business with Eagle”
Eagle has become an integral part of ensuring we deliver safe compounds and maintain the quality that allows us to have trust among pet owners and veterinarians. We utilize a triple-check system to test our compounded medications and rely on their superb service and expertise on a regular basis. The level of competence exhibited in the representatives I deal with gives me confidence as a pharmacist, and I’m delighted to be doing business with Eagle.
Danny Carrero, Rph, President of Best Pet|Rx – New York, NY