Compounding Pharmacy
503A GAP Analysis

Know where your pharmacy needs improvement in all matters of compliance. Make cost-effective, prioritized adjustments.


Ready to Safeguard Your Business?

Why Schedule A GAP Analysis? Learn More Below.

Did You Know that failure to meet only one of the conditions under
section 503A will require your facility to follow CGMP requirements?

503A Exemptions Are All or Nothing

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 Can Help

With so many regulations, guidelines, and standards, it can be overwhelming trying to assess if your facility is in line with regulations. Are you prepared for the inevitable knock at the door? How can you ensure there are no gaps in your operation which may lead to costly outcomes?

  • Let our team thoroughly evaluate your operation. We will audit your facility according to the same guidelines used by FDA investigators.
  • Following our audit, we’ll supply you with a comprehensive report, so that you know the corrective actions to make in order to achieve compliance.

Here's What Our Gap Analysis Audit Covers

Aseptic Processing

Our Experts Will Perform a 2-3 Day Audit
Assessing Your Pharmacy’s Quality Systems Including:

  • Environmental Monitoring
  • Aseptic Processing and Technique
  • Equipment
  • Documentation System
  • Training Records
  • Process Control
  • Finished Preparations Testing
  • Quality Assurance Program

Get Started Today