Life Sciences
GMP and GTP Cleanroom Design and Commissioning
Expert support for GMP and GTP compliance from manufacturing into the clinical setting.
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 the facilities that support the manufacturing of products as well as the actual science and process details of the products themselves.
WorkingBuildings Clinical, part of Trinity Consultants, is led by an unparalleled group of specialists comprised of engineers, architects, certified energy managers, and drug manufacturing subject matter experts, giving us a well-rounded perspective that is part of our competitive advantage in supporting clients with GMP and GTP compliance.
Our team assists with manufacturing facility and program design and works closely with scientific staff to understand their processes and help transfer them into the manufacturing phase and onward into Phase 1, 2, and 3 clinical trials. Our distinct competitive advantage is our team’s direct practical experience with a wide array of modalities that equips us with a full-spectrum view of the challenges and opportunities presented to clients within R&D and clinical settings.
Our services include:
- HD exposure + risk management
- 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
- Ongoing operations support including Environmental Monitoring Committee membership
How Else We Can Help
Related Services
Healthcare Facility Design and Commissioning
Expert commissioning to ensure reliable and compliant patient care.
Compounding Pharmacy Program Support
Comprehensive USP <797> and USP <800> compliance support for compounding pharmacies and healthcare systems.Our Results
Featured Projects
Compounding Pharmacies Ensure Cleanroom Compliance
WorkingBuildings provided regulatory compliance, commissioning services, and much more to support the healthcare system's design and construction teams.
Trinity's SafeBridge Group Identifies Chloracne Source in Research Lab
SafeBridge investigated an outbreak of chloracne in a discovery lab at a top 5 pharma company, determined the novel compound responsible for the outbreak and recommended a safe course of remediation.Service Specifics
Current Good Manufacturing Practices (CGMP)
Our expert team has 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 US 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.
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 to help our clients solve their biggest developmental and operational challenges.
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 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 critical for the proper compounding of sterile preparations and ensuring patient and 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 to achieve compliance. We also assist our clients in all phases of establishing and maintaining 503 A & B programs.
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 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 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.
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 into 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.
Hazardous Drug (HD) Exposure and Risk Management
With the publication and enforcement of USP <800>, it is critical that healthcare systems are 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 protect these clinical staff members during preparation and administration activities. Our integrated team of USP compliance experts, WorkingBuildings and SafeBridge, provides comprehensive USP <800> services.