cGMP Validation Services

When it comes to satisfying FDA qualification requirements, Technical Safety Services (TSS) offers unparalleled experience, quality and support. We share your dedication to the standards and good manufacturing practices that ensure the safety of the PHARMACEUTICAL AND BIOTECH INDUSTRIES from research and development to manufacturing and packaging.

TSS’ validation services provide documentation to demonstrate regulatory cGMP compliance; current and acceptable equipment certification and qualification; and communicate your quality standards. Trust TSS with all your cGMP validation requirements.

TSS cGMP validation services involve comprehensive project management to ensure your validation results adhere to all regulatory and industry expectations. Our experienced, detail-oriented project management team ensure you receive the same peace of mind from our cGMP validation services that you pass along to your customers.

TSS specializes in:

  • CLEANROOM/HVAC QUALIFICATION to demonstrate your controlled environment consistently delivers the state of control required for uninterrupted usage
  • 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

It’s important to note that cGMP validation can be required at several stages of facility and equipment lifecycles. TSS services include:

  • Installation Qualification [IQ]
  • Operational Qualification [OQ]
  • Performance Qualification [PQ]
  • Full cGMP Documentation Protocols and Validation Summary Reports: Pass any regulatory or client cGMP audit with extensive, comprehensive documentation packages.
  • 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 800-877-7742 or CONTACT THE TSS REGIONAL OFFICE nearest you.

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Validation: Temperature-controlled Units