Quality Assurance and Quality Control for
All-Under-One-Roof GMP Operations

Quality Policy

T&T Scientific was founded to provide end users and customers with liposomal and lipid-nanoparticle equipment , research and development, and manufacturing services, ultimately to help them achieve their goals in bringing life changing and life saving technologies to the world. T&T Scientific Quality Policies are stated below:

Foster a quality mindset that promotes a passion for continual improvement.

Ensure compliance with all applicable regulatory requirements.

Guarantee safe and effective products and services that fulfill customers needs.

Compliance

Each department is a discrete functional unit of the organization, and a quality centric approach is at the core of all that we do here. T&T’s Quality Operations are governed by the site’s Quality Manual. T&T Scientific Corporation’s Quality Management System takes it guidance from 21 CFR Part 820 Quality System Regulations and complies all FDA GMP regulatory requirements including 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 11. The company claims no exclusions from the 21 CFR Part 820, 201, 211, 11 at 7140 Regal Lane, Knoxville, TN 37918.

Inspection History

T&T is registered with FDA, reference FDA registration # 3015266446. T&T’s quality systems, SOPs, policies, and infrastructure are aligned with FDA, EMA, and JP regulatory requirements in order to develop and manufacture drug product to support Pre-Clinical and Clinical trials. All potential clients are invited to come tour our facility and conduct a contract-enabling audit. It is highly recommended to do so. It allows both teams to start to build a rapport and better understand our operations. However, given the pandemic and other time constrictions, we realize this is not always possible. Last year, we accommodated several virtual audits by conducting virtual tours, Zoom interviews, and document reviews. The last onsite audit was a one-and-a-half- day audit conducted on 01-Mar-21 by an overseas client who entered into a Pre-Clinical/Phase 1 development and manufacturing contract with us afterwards. The audit reviewed the entire quality system, as well as aseptic fill/finish processes. The first Clinical batch is scheduled to be filled in September 2021.

With a strong Quality presence on the manufacturing floor, we have been able to successfully provide material for IND filings in both US and EU markets.

Fully Integrated Electronic Quality Management System (eQMS)

Upon execution of the proposal, the project team is selected and responsibilities are assigned in T&T’s project management software (Monday.com) and T&T’s electronic quality management system (eQMS), Qualio. An assessment of the risks and potential problems associated with the product transfer is necessary to identify, assess, and set actions for risk mitigating activities. This risk assessment process is governed by procedure and is documented using a FMEA template for this assessment. This assessment should address any potential impacts to current portfolio, compliance, quality, safety, etc. A preliminary review of the potential risks of cross contamination associated with introduction of new raw materials and APIs are reviewed for special handling and sampling considerations. The potential risks of cross contamination associated with introduction of new raw materials and APIs are reviewed. The assessment focuses on, the following types of products/materials: cytotoxicity, antibiotics, cell products, etc. This risk assessment shall be included in the change control associated with the project.

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