Published Articles

Tunnell’s subject matter experts have written a number of informative pieces. Here are a sampling of articles that have been published in leading industry publications.

PAI Readiness – A Journey, not an Event

Jun. 2018 – Tunnell’s Walter Matzmorr discusses the cross functional process of planning for a Pre-Approval Inspection.

Data Integrity Deviations, and Shop Floor Quality

Jun. 2018 – Kip Wolf explains why there is no “quick fix” for improving data integrity and data quality–it remains a journey of continuous improvement.

Also Read it at:
Bioprocess Online
Outsourced Pharma

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.

Where EDMS Fails:  Data Integrity Pitfalls to Avoid in Metadata for Life Sciences Products 

Mar. 2018 – Tunnell’s Kip Wolf explains how firms that create and manage electronic documents can improve compliance.

Using Lean Strategy to Improve Efficiency in Pharmaceutical QC Labs 

Mar. 2018 – Tunnell Consultants Greg Anthos and Scott Myers explain how a company reduced its 15-day throughput time by 30% within 3 months.

Why You Should Engage With Regulatory Early in Product Development 

Feb. 2018 – Tunnell Principal, Kati Abraham, explains the importance of early regulatory engagement.

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

Jan. 2018 –  Tunnell Managing Consultant, Kip Wolf, discusses observations of CGMP violations involving data integrity.

Information Management Strategies to Improve Data Integrity During M&As 

Nov. 2017 – Tunnell Managing Consultant, Kip Wolf, discusses the challenges to M&A integration and “maintaining  business continuity, transferring appropriate knowledge, and transferring information assets in a timely and effective manner.”

In Defense of the Anti Generic 

June, 2017 –  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

June, 2017 – “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

April, 2016 – The key to successful technology transfer and facility startup is in strong project management, and it may make all the difference between a successful launch and one plagued by delays. Careful planning can help avoid the pitfalls often found in transferring processes between facilities. This article in BioPharm International, by Tunnell’s Walter Matzmorr, discusses the complexities inherent in technology transfer, and details how to successfully shorten time-to-market and avoid costly mistakes.

Manufacturing’s True North: The Quality Compass

August, 2015 – Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing. Here are key steps and strategies that can make a difference–and deliver bottom-line results.

Quality Agreements for Contract Manufacturers

September, 2014 – A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

State of Quality and Compliance in the Biopharmaceutical Industry

April, 2013 – Have FDA initiatives improved manufacturing quality and patient safety?

Operational Excellence: More Than Just Process Improvement

October, 2013 – By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.

Through the Lens of Lean

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

Connecting QbD, Knowledge Management and Supplier Quality Management

November, 2012 – Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

Risk Based Decision Making

March, 2012 – Focusing on how risk affects the entire organization can improve the business bottom line.

Reduce Analytical Testing and Costs Without Compromising Compliance

July, 2012 – Unnecessary analytical testing can lead to unnecessary costs.

QbD:  The Case for Change

March, 2011 – Executive management leadership is essential in the effective implementation of QbD.

QbD:  The Case for Change (Part 2)

May, 2011 – A rigorous cost benefit assessment can help to chart a cost-effective path forward.

QbD:  Time to Market 

Dec., 2011 – Are you factoring in the potential cost of unexpected failure?

Supply Chain Transformation:  Strategic Necessity for the Life Sciences 

March, 2011 – New supply chain challenges, including counterfeits, are forcing companies to act in different ways to secure produce safety.

Impact of cGMP on Supply Chain 

July, 2011 – Incorporating regulatory requirements into the product life-cycle plan is crucial for supply chain security and patient safety.

Keys to a Successful Technology Transfer 

Feb, 2011 – Poor planning and misguided implementation when conducting technology transfer can lead to problems with budget, scheduling, compliance and supply.