WB | Clinical

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.

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.

Our 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.

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.

With the publication of USP <800> and enforcement as of December 2019, it is critical that your Health System is equipped to ensure ongoing and sustainable compliance for managing hazardous drugs (HD). USP 800 applies to all healthcare personnel who handle hazardous drug preparations and any entity that stores, prepares, transports, or administers HDs. Pharmacy and Nursing personnel are the most common staff that are exposed to hazardous drugs and many healthcare facilities have already taken extensive steps to protecting these clinical staff members during preparation and administration activities. Read more here