Published Articles - Tunnell Consulting

Quality Agreements for Contract Manufacturers

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

Have FDA initiatives improved manufacturing quality and patient safety?

Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

October, 2012 – Lean may have been designed for manufacturing, but it can also transform quality control labs.

Unnecessary analytical testing can lead to unnecessary costs.

Focusing on how risk affects the entire organization can improve the business bottom line.

Are you factoring in the potential cost of unexpected failure?

Incorporating regulatory requirements into the product life-cycle plan is crucial for supply chain security and patient safety.

A rigorous cost benefit assessment can help to chart a cost-effective path forward.

New supply chain challenges, including counterfeits, are forcing companies to act in different ways to secure produce safety.

Executive management leadership is essential in the effective implementation of QbD.