Quality at Every Step: 503B Outsourcing Facilities Master Safety and Sterility Standards

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In a time where businesses everywhere are re-evaluating their safety and cleanliness practices for client and employee safety, 503B facilities are built to maintain the highest standards from the ground up.

503B outsourcing facilities comply with FDA regulations for drug manufacturing and are held to a higher standard of quality and safety.

Two key standards for 503Bs are:
  1. Regular reporting and facility inspections to evaluate and reinforce the use of approved drugs and minimize the risks during patient treatment.
  2. Adherence to Current Good Manufacturing Practices (CGMP).

While 503B facilities offer bulk medications that help veterinary hospitals reduce risk and improve patient outcomes, a glimpse inside Epicur Pharma gets to the heart of it: aseptic cleanroom practices, automation, and safety controls at every step.

To bring the same level of FDA standards for human drugs to veterinary medications, Epicur’s 503B outsourcing facility uses environmental monitoring to identify and mitigate potential microbial contamination of aseptic manufacturing areas. The air, surfaces, operation, and personnel are monitored to support aseptic conditions during the manufacture of sterile drug products. This includes ensuring all employees practice proper procedures to reduce contamination risks and complete thorough documentation for tracking and trending of monitoring results. This monitoring is required to provide high-level assurance of product sterility because, alone, finished product testing is not enough.

At Epicur, our team follows a strict gowning process before starting their shift. Street shoes are discarded when they enter the building, and employees must enter a multi-stage gowning room with extensive protocols to remove the risk of shedding and contamination.

The white gowning is Epicur’s sterile gowning, which is worn within the cleanrooms during aseptic filling. This gowning is monitored in-process and upon completion of aseptic processing of sterile products. 

Epicur’s blue gowning is worn during the compounding of the batch, which is non-sterile at that point in the process.

While few outside visitors are allowed in the facility, as our guest, you’d see at a glance the steps maintained each day to ensure cleanroom safety standards. Beneath the surface, 503B facilities invest in protocols, processes, and technology to ensure purity and sterility for every product that leaves our facility. This investment pays off for the veterinary hospitals we work with, and for the health and safety of everyone in our care.

Extensive automation helps to ensure that drug manufacturing and packaging is precise and consistent, vial to vial, batch to batch.

Current Good Manufacturing Practice

The FDA’s Current Good Manufacturing Practice, specifically 21 CFR Part 210 and 211, is a set of rigorous and detailed guidelines that must be followed when drug products are manufactured to ensure the safety, quality, and purity of the finished product. According to the FDA:

“CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.”

These guidelines, which vary according to the specific manufacturing operations of each 503B facility, generally include:

  • Facility design and cleanroom standards
    To maintain an aseptic environment for the manufacturing of products, advanced clean rooms and certain facility design elements are essential, including air quality, humidity levels and temperature as well as preventing contamination or errors during manufacturing operations.
  • Source control of drug components
    All components must be purchased directly from an FDA-registered vendor and approved or qualified, independently, by the purchasing facility to ensure the vendor provides components that meet specified standards.
  • Clear cleaning protocols
    All 503B facilities must create, execute, and document cleanings developed using specified protocols. For proper sanitization, approved disinfectants, cleaning schedules, and equipment must be pre-approved before implementation.
  • Manufacturing processes and controls
    Documented manufacturing process steps and quality checks are performed during batch manufacturing. This is capture in the batch record, which tells the story of the manufacturing process from starting materials to finished drug products.
  • Testing capabilities
    Written procedures for material/product sampling and testing must be established. Additional laboratory controls are in place to ensure testing reliability for all components, in-process materials and finished drug products.
  • Labeling guidance
    Labeling requirements include the facility of origin and drug specifications, including but not limited to: expiration date, active and inactive ingredients, manufacturing date, and storage and handling instructions.

Regular inspection and review of any recalls, the inherent risk of specific drugs, any drugs which appear on the FDA’s drug shortage list, and adherence to the above practices help to ensure the quality, sterility and potency of the medications you prescribe.

View our product portfolio to learn more about the compounded medications we manufacture.

To learn more about the importance of CGMP 503Bs, download our white paper:

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