Process/Product Design Control and Validation

TNTC Inc. has project managers (PMs) and engineers experienced in Process and Product Qualification and Validation. Through our process oriented methodologies (POM) we provide maximum value throughout the process/product lifecycle.

Using the same methodology, TNTC can provide risk based product qualification for medical devices and combination products utilizing applicable FDA guidelines and regulations in (21 CFR Parts 210 and 211), Active Pharmaceutical Ingredients (ICH Q7A), and for Medical Devices (21 CFR Part 820). Required elements and information can be easily included on your design history file (DHF) or DMR (device master record).

The value to the client is in knowing you’re releasing the right product to the patient market. By implementing TNTC’s POM into the process and product validation, a near-perfect product can result in the release to market.

TNTC provides practical solutions based on ASTM E2500-07 and ISPE guidelines that provide quality to the engineering process and delivers a more cost-controlled, efficient project. TNTC solutions and process oriented methodology apply the concepts and principles introduced in the FDA’s document titled ‘Pharmaceutical cGMPs for the 21st Century-A Risk-Based Approach’, and in the ICH Q8, ICH Q9, and ICH Q10 documents