503B Audits and Services

Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP requirements.

Outsourcing facilities:

• Must comply with CGMP requirements,
• Will be inspected by FDA according to a risk-based schedule, and
• Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound.

While there are obvious financial benefits to registering as a 503B facility, operating under cGMP is a new regulatory landscape that most pharmacists have never dealt with.  Thus they may not be aware of the regulatory requirements, the interpretation of the regulations, and how to prepare for the initial FDA inspection.

As listed on the FDA website, over 150 503B facilities received an FDA Warning Letter and many pharmacies were not designed, qualified, or maintained to meet the cGMPs for finished pharmaceuticals.

Aseptic Enclosures can help you navigate the cGMP regulatory minefield and not only help you meet cGMPs but also help you understand them. Call 800.418.9289 and inquire about our 503B oriented services.

Some of Aseptic Enclosures Capabilities

• Audit & Consultation
  • Pre-registration consultation (cGMP scope determination).
  • Mock-audit to review documentation and provide training to the staff
• Pharmacy Planning & Design
  • Based on the Audit and consultation we prepare a pre-registraton floor plan for 503B compliance
  • Cleanroom compliance
  • Floorplan assessment
  • Environmental prediction
  • As found model development
  • Architectural site plans
  • CAD turnovers for easy application
  • Pre – Fabricated modular rooms installation
• Training
  • Aseptic techniques
  • Maintenance, calibration, and facility related issues
• Equipment Manufacturing
  • Custom clean room equipment
  • Upgrades and expansions of your current equipment
  • Equipment maintenance
  • Design Qualification/Enhanced Design Review
  • Workflow dynamics assessment