Medical Testing Laboratory
Location: Mississauga, ON
Size: 27,000 ft2
Advanced science-based innovation with analytical and bioanalytical testing across the pharmaceutical, cannabis, and nutraceutical industries.
Business expanded exponentially and had a requirement to select, design, construct, move and go-live while maintaining all regulatory, client and safety requirements. As well, to keep all aspects of the offices, laboratories, and technical teams active – no down time.
Space expanded by 7 times – 3,800 sq. ft. to 27,000 sq. ft. and required extensive planning, coordination, and regulatory activities to be moved while the business remained operational throughout the entirety of the process.
New lease, multiple regulatory bodies, budget considerations, risk mitigation and extremely high-risk processes and products required to be identified, mapped, measured, managed, moved, reset, calibrated and approved.
Together with equipment and building items, consideration was given to chemical movement, refrigeration unit specifications, calibration, chain of custody, warranties, and safety of the teams.
Integration of Tessier Design Corp.’s proven best practices, the project team, in collaboration with the client and vendor partners:
- Formal asset list build, audit, and documentation process
- Data management of all systems, chemicals, and documentation
- Decommissioning best practices by approved resources
- Quality management system aligned with regulatory requirements such as:
- Health Canada Good Manufacturing Practices Guidelines (GMP)
- US FDA current Good Manufacturing Practice (21CFR Part 210, 211 and Part 11)
- Health Canada GLP Regulation (based on OECD GLP Principles)
- Good Laboratory Practices (21CFR Part 58)
- ISO 17025 for Testing Laboratories
- Risk management process designed, built, and implemented for chemical packaging, movement, unpacking and stability testing
- Data security protocols presented, approved, and audited specific to tamperproof requirements
- Design and space plan reviewed and audited
- Scope documents prepared for move RFP together with SLA’s and guarantee’s
- Uncompromised quality control
- Schedule leadership for movement of all assets – schedule included time (to the minute for some chemicals), people, vendor and audit requirements
- Disposal of decommissioned equipment, tools, furniture, samples and chemical
Client secured the space, managed client expectations, conformed to all regulatory requirements and continues to expand it’s business.
Other successes can be described as:
- Zero risk escalations
- Move completed in three phases over two days each
- Data integrity maintained
- No chemical loss (sample or supply)
- Budget managed with company and landlord
- Marketable message to all of the companies employees, vendors, clients and leadership