Technical Safety Services (TSS) helps pharmaceutical and biotech companies meet FDA cGMP and EU GMP requirements across the full product lifecycle – from R&D through manufacturing and packaging. TSS offers unparalleled experience, quality and support, with over 15,000 customers serviced nationally. TSS’ qualification & validation engagements are built around our deep industry & regulatory expertise – we are more than a qualification project management team. From initial risk assessment, QMS development, into qualification protocols and onsite execution, TSS can support in any way you need. We are here to help you ensure that your processes and facilities meet all the standards required by cGMP to protect product quality, patient safety, and regulatory compliance.
TSS specializes in:
- CLEANROOM/HVAC QUALIFICATION to demonstrate your controlled environment consistently delivers the state of control your operation depends on
- BUILDING MONITORING/AUTOMATION SYSTEM QUALIFICATION to ensure your monitoring system is reliable and properly configured to deliver the data and trending you require
- BIOSAFETY CABINET QUALIFICATION to confirm your cabinet consistently performs to deliver your critical ISO 5 environment
- Thermal qualification of incubators, refrigerators/freezers, warehouses (including cold storage) and environmental chambers to deliver the data required to demonstrate regulatory compliance and consistent storage conditions. Proper temperature and environmental control is a key part of manufacture, handling and storage for many pharmaceutical and biotech products.
- STERILIZATION QUALIFICATION OF AUTOCLAVES, providing confirmation all cycles and loads processed provide adequate sterility assurance
- Water Systems Qualification – from PW to WFI, we support qualification in all phases, including sampling plans, chemical and microbial testing through our in-house ISO 9001/17025 laboratories, and all required system specific tests
- Compressed gas systems qualification – clean compressed air, nitrogen, or other process gases used in direct or indirect product contact, in compliance with ISO 8573 and applicable regualtory or pharmacopeial standards
- And More – cGMP qualification of any and all processes and equipment, contact us to learn more about how we can support your full validation program.
It’s important to note that cGMP validation can be required at several stages of facility and equipment lifecycles. Whether you have a new build, an upgrade, or re-qualification, TSS is here to help with services that include:
- Consulting & programmatic support – TSS can provide full compliance program support, from risk assessment, URS, and VMP development, to on-site execution of qualification activities.
- Installation Qualification (IQ) — Verifies equipment is installed correctly per manufacturer specifications and facility design
- Operational Qualification (OQ) — Confirms equipment performs correctly across its intended operating range.
- Performance Qualification (PQ) — Demonstrates consistent performance under routine production conditions.
- SOP review and development
- Full cGMP documentation protocols and validation summary reports — Audit-ready packages built to withstand regulatory and client scrutiny.
- Re-qualification services
ISO 9001 Certified Quality
TSS maintains an ISO 9001-certified quality system and, as with all the services we offer, OUR TRADEMARK QUALITY is built into every aspect of our qualification services. Put the best qualification team in the business to work for you today.
For more information or to schedule a free consultation, call 866-231-2861 or CONTACT THE TSS REGIONAL OFFICE nearest you.
