Published Articles - Tunnell Consulting

Losing Sight of the Intended Purpose of Specifications Has Consequences for the CMO-Sponsor Relationship

Mar. 2018 – Julia O’Neill discusses current practices for specification-setting in the pharmaceutical industry.

Why You Should Engage With Regulatory Early in Product Development

Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.

Cheating In The Lab: 3 Data Integrity Pitfalls to Avoid in Laboratory Operations

Tunnell Managing Consultant, Kip Wolf, discusses observations of CGMP violations involving data integrity.

Information Management Strategies to Improve Data Integrity During M&As

Tunnell Managing Consultant, Kip Wolf, discusses the challenges to M&A integration and maintaining business continuity, transferring appropriate knowledge, and transferring information assets.

In Defense of the Anti-Generic

This article in Pharmaceutical Manufacturing quotes Tunnell’s Scott Myers on the role of authorized generics in today’s competitive generics marketplace.

Quality Culture: Getting it Right the First Time

“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality,

“Minimum viable product” may work well for software, but pharma needs to get it right the first time, and develop a culture of quality, tied to metrics, and encouraging change where the work actually takes place. This article in Innovation Excellence quotes Tunnell’s Al Riles and Bob Johnson on defining the four components of a quality culture.

Integrating Technology Transfer and Facilities Startup for Biologics

The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference.

Manufacturing’s True North: The Quality Compass

Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing.

Quality Agreements for Contract Manufacturers

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

Operational Excellence: More Than Just Process Improvement

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

State of Quality and Compliance in the Biopharmaceutical Industry

Have FDA initiatives improved manufacturing quality and patient safety?

Connecting QbD, Knowledge Management and Supplier Quality Management

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