Partnering for 503B Compliance

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Consulting with a 503B Facility to Address Issues and Meet New Regulations as a 503B Outsourcing Facility

DYNALABS expertise in the Pharmaceutical Industry enables us to act as a partner to our clients, not just as a testing facility. Instead of just providing test results, we can provide solutions to a variety of issues that impede our clients’ success.

This case study will show how DYNALABS was able to assess a client’s facility, provide a plan to address issues impeding their success as a 503b outsourcing facility, and follow through with them to improve their business. By providing the full package to assist this client, DYNALABS was able to take steps outside of the expertise of most cGMP consultants to grow the client company.

The Issue
Like many other facilities, Facility B was struggling with the requirements for 503b regulatory compliance. As part of those struggles, Facility B was the recipient of an FDA 483 and warning letter. The FDA was concerned with the suitability of their preparations of sterile compounds.

So, Facility B began looking for a knowledgeable consultant to work as a business partner to assist them in meeting the new regulations as a 503b outsourcing facility. The solution needed to fit their budget and provide a focus that addressed not just the regulations, but the success of their business.

The Solution
Facility B’s search led them to DYNALABS.

DYNALABS experts began by performing a two-day audit of Facility B. The experts assessed the facility against the Code of Federal Regulations for cGMP facilities, chapters 210 and 211. While there, the DYNALABS experts also walked through existing compounding processes with Facility B staff to determine points of possible contamination. The DYNALABS experts were immediately able to identify issues with both the facility and compounding processes.

The result of the audit was a detailed gap analysis of the facility and quality department. DYNALABS presented the analysis to Facility B with a plan for making improvements.

Together, Facility B and DYNALABS began working on the necessary improvements, beginning with equipment documentation. Facility B stopped compounding for a short time as they executed facility documentation that led to rebuilding their cleanroom and its HVAC unit to meet a higher level of standards.

The Result
Within six months Facility B completed rebuilding their cleanroom suite and become more comfortable dealing with 503b regulations. They continue to work on internal improvements with the goal of completion within six to twelve months.

Facility B continues to partner with DYNALABS. They consult weekly to enable Facility B to receive assistance with issues as needed.