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WB | Clinical

When the experts need help, they call our clinical team.

USP <797>, <800>, and 503 A & B

We offer a wide variety of services to pharmacies to assist in compliance with USP <797>, <800>, <823/825> and with FDA 503 A & B pharmacy programs. We review your pharmacy engineering and administrative controls; operations; behaviors and practices of compounding personnel; environmental conditions and monitoring; labeling and storage procedures; and a number of other areas that are critical for the proper compounding of sterile preparations and patient, as well as, personnel safety. We create an action plan comparing current practices against the requirements of USP <797> and <800> and items that need to be addressed in order to achieve compliance. We can assist in all phases of establishing and maintaining your 503 A & B programs as well.

Pharmacy Compounding Standard Operating Procedures

Accurate and updated policies and a well-trained staff are crucial to ensuring the safety of patient care and medication compounding. Our team of compounding experts will work with you to review your existing cleanroom workflows and develop a complete set of Pharmacy Compounding Standard Operating Procedures to ensure compliance with USP <797> ,<800>, and <823> (if applicable), FDA and the FDA Sections 503A and B, and State Boards of Pharmacy. Staff training sessions are also available to ensure pharmacy, maintenance, and environmental services staff are compliant with the revised SOPs. Topics addressed will include: Compounding facilities and engineering controls, HVAC and HEPA filters, environmental monitoring and control systems, cleaning and disinfecting, environmental monitoring, aseptic technique, garbing and hand hygiene, and others.

Drug Delivery

We help medical device and pharmaceutical companies bring innovative new drug and biologic delivery systems to market safely and effectively. We provide risk assessment, program development, engineering support, facility operations and operational Q&A support. From initial concept to regulatory approval, we bring together world-class expertise helping you solve your biggest developmental and operational challenges.

Current Good Manufacturing Practices (cGMP)

The WorkingBuildings Clinical Team includes professionals with over 120 years of combined experience in the field of GMP and GTP cleanroom design, construction, commissioning, qualification, and operations. Our depth of knowledge covers the engineering and administrative controls; of not only the facilities that support the manufacturing of products but the actual science and process details of the products themselves.

We have extensive knowledge of the Code of Federal Regulations 21 CFR Parts 210, 211, 212, 1271 and others, as well as HCT/P compliance and Quality Systems regulations in the U.S. and EU. Our biologics experts have a complete understanding of GMP and GTP regulatory requirements, and work closely with scientific staff to understand their processes and help transfer them into the GMP manufacturing phase and then into the clinical setting.

cGMP for Cord Blood

Our services for cord blood banking go beyond the physical facility. We ensure the design of the facility complies with the FDA regulations regarding the movement of people, equipment, and supplies in and out of the space. During construction, whether for modifications or a new build, we provide construction quality control (CQC). We also check for appropriate redundancies in critical systems and verify environmental monitoring for temperature, relative humidity, differential air pressure, and documentation compliance.

Our cGMP expertise is critical to your success.

Services Include:

  • Manufacturing Risk Analysis
  • Market Studies
  • Facility & Program GAP Analysis
  • Consolidation Studies
  • Programming + Basis of Design
  • Design Services
  • Systems & Equipment IQ/OQ
  • Continuous Quality Control
  • Commissioning
  • ISO Cleanroom Certification
  • SOP Development & Training
  • Compliance Plan Set
  • As-Built Documentation
  • Modular/Mobile Swing Space
  • Multi-Site Program Management
  • Training
  • GMP Engineering Controls

Project Examples

Duke University

Duke University

The Clinical Division of WorkingBuildings is providing a wide range of operational and ongoing compliance services at the Duke University Carolinas Cord Public Blood Bank, and the Duke University Robertson Cell Therapy CGMP Manufacturing Center.

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David H. Murdock Research Institute

David H. Murdock Research Institute

The Clinical Division of WorkingBuildings operated and managed the David H. Murdock Research Institute vivarium. The animals in our care included immuno-compromised animals, non-human primates, and regular research rodents.

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University of South Alabama Laboratory of Infectious Diseases

University of South Alabama Laboratory of Infectious Diseases

WorkingBuildings provided Owner’s representative services, SOP development, and commissioning services during the repairs of University of South Alabama’s new Laboratory of Infectious Diseases. After the completion of the repairs, WorkingBuildings provided transitional services to ensure...

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