WB Clinical provides a broad scope of services to support USP <797>, <800>, <823> pharmacies, and 503 A & B programs
Our Services include:
Gap Analysis: Our on-site team will review your pharmacy engineering and administrative controls and operations, and can even review the 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 therefore patient safety. From this on-site visit, a gap analysis and action plan can be created, comparing current practices against the requirements of USP <797>, <800> and <823> (if applicable), FDA and the FDA Sections 503A and B, and State Boards of Pharmacy.
Consolidation Studies: Our teams are responsible for analyzing collected data, gathered during discovery analysis, with the goal of determining the lowest possible number of unique manufacturing and compounding sites that may be targeted for modification and/or improvement. The purpose of this analysis is to identify opportunities to consolidate the various sites into a fewer number of sites, which when properly managed should lower cost to institution without impacting throughput.
In conjunction with a gap analysis, or based on existing action plans, we can assist in all of the steps necessary in order to make your operation fully compliant with USP <797>, <800> or 503A/B, including facility design and build consulting (described below).
Facility Design & Build Consulting: We can assist in the renovation of an existing pharmacy operation, or in the development of a new pharmacy. We will work with you and your architects and engineers, and can even provide turnkey services with our engineering teams, to create a set of design and performance criteria that will meet or exceed the requirements of USP <797>, <800> and 503A/B.
Programming & Basis of Design
This service begins by analyzing your process and the proposed manufacturing space to verify that the available space and infrastructure systems are suitable for your needs. Following the verification of as-built conditions of the space and installed systems, we will work with your staff, the architect, and others that you select to program a functional facility, based on the manufacturing need and SBOP or FDA regulatory requirements. We will use the information we obtain to develop a compliant and functional floor plan. One goal of this phase is to drive the construction and operational costs to the lowest level reasonably achievable.
Services begin by developing distinct specifications for inclusion into the Construction Documents prior to bidding and publication. We will coordinate continually with you and the architect / engineering team – in a manner that you direct – to ensure that the Construction Documents align exactly with the basis of design.
To guide the MEP engineering team, we will produce a detailed Equipment Binder that lists all built in and moveable equipment that will be used in the facility. We will also produce a complete set of Flow Diagrams—Personnel, Waste, Supply, and Product. Following your approval of the scope document, we will develop the detailed Basis of Design document that will be used by you to inform your staff and engineers as they craft the Construction Documents. This includes a Differential Air Pressure (DAP), direction of flow & ISO Classification map of the space.
Facility SOP Development and Training
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.
Additional Support Services
Multi-site Program Management: WB can offer specific qualified senior Program Managers with extensive construction management for the delivery of multiple locations, scheduling all activities to allow for savings in both time and capital cost.
Modular/Mobile USP <797> & <800> swing space to keep your pharmacies up and running even during renovations programs. Our modular program allows existing pharmacies to continue during the renovation phase and can be transported from location to location during a large conversion program.
Training: A customized training program, whether on-site or online, can be developed in order to fully educate pharmacy personnel in any aspect of compounding sterile preparations, including aseptic technique, environmental monitoring, engineering controls, cleaning and disinfecting, and many more.
Standard Operating Procedures: We offer a wide range of standard operating procedures that include both pre-written templates, which have been proven in both pharmacy and manufacturing operations, as well as custom documents for any type of operation.