May 28, 2015

Change in Pharmaceutical Manufacture

Change, planned or unplanned, 
is imperative in pharma manufacturing.

by Peter Murray, 

1. The concept of change

Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

All these activities are related to change, whether that change is planned or unplanned. While separate terms can usefully serve to focus attention on detail in particular activities when dealing with the consequences of change, treating them as isolated activities can lead to confusion and inconsistency of approach to what are logically very similar and/or closely related processes.

May 26, 2015

5 Tips for Winning Executive Buy-In for a New QMS

These five strategies will help convince 
the executives and departments in your 
organization to support your proposal for a 
new EQMS or an expansion of your current system.
by Matthew M. Lowe
Executive Vice President, MasterControl Inc.

If you’re facing executive or organizational resistance to your plan to automate your quality system, you’re not alone. There are many quality and IT professionals who are in the same boat. They have the toughest time convincing senior management not just about the merits of an electronic quality management system (EQMS) but about the real value of quality.

My colleague, Marc Vandenbulcke, and I facilitated a group discussion at the recent Masters Summit to explore common problems when proposing a new EQMS or expansion of your existing EQMS (1). We had a lively discussion with MasterControl customers who come from highly regulated companies.

With valuable input from participants, Marc and I came up with five strategies that will help convince the executives and departments in your organization to support your proposal for a new EQMS or an expansion of your current system.

May 21, 2015

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here! 
What's an SOP?"
by Laurie Meehan
Social Media ManagerPolaris Compliance Consultants

“What tipped you off?”
“How did you know to look there?”

When our GCP auditors conduct training and deliver guest lectures, they frequently hear those questions from class attendees. Sometimes the tip-off is something very subtle that requires the keen eye of an experienced auditor to notice. And other times, not so much.

The Principal Investigator and Study Coordinator comments below are real; these are conversations our auditors had with site personnel. Really. No kidding. Pinky swear. The audit findings, not surprisingly, are real too. I do confess to having taken some liberties with the Auditor Notes and Remediation Recommendations.

May 19, 2015

Cosmeceuticals: the Good, the Bad and the Ugly

What is a cosmeceutical?  Is it a lotion, 
a shampoo, shaving cream? 
Or is it something else?

By William L. Schwemer

Since retiring from FDA, I have assisted numerous businesses in developing labels for “Cosmeceuticals.”  I have also presented a number of training programs on the manufacturing and marketing of such products. When I was asked to write something using this specific title, I thought I would be able to quickly put an article together.  At first, I had a difficult time putting pen to paper because I couldn’t think of anything “ugly” about cosmeceuticals as I define them.  To get started I searched the Internet to see what others were saying about these products.

May 14, 2015

The Bright Future of Quality and Compliance

Executive Vice President, Operations

Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?

Only three decades ago, all business computing capability resided in the hands of programming and IT specialists. If you needed any computational or data power to perform your business function, you were referred to the computer department. They queued your request and later dispensed the results—a report or an analysis. The methods and tools of their craft remained mysterious to most. Yet their expertise in the arcane enabled the critical functions of business.

May 12, 2015

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

When quality and compliance are incorporated into 
operational excellence strategies, companies are able
 to thrive in the competitive life sciences marketplace. 

by James Jardine

Marketing Communications, MasterControl

Increasingly strict regulatory measures are drawing attention to the inadequacy of the systems and processes life sciences companies use to manage quality and production. A new eBook from LNS Research entitled A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences outlines some of the major challenges faced by life sciences companies and shows how prominent organizations are successfully handling those difficulties. 

You can download a free copy of the eBook here.

The eBook highlights a variety of timely topics, including:
  • the pressures placed on life sciences companies by the cGMP regulations set forth by regulatory bodies like the FDA 
  • the benefits of “holistic” quality management 
  • some examples of leading organizations’ approaches to quality challenges 
  • data demonstrating the effectiveness of electronic quality management 
  • systems recommendations for improving quality going forward

May 7, 2015

A Business Case for Engendering Trust in Your Company

Building and maintaining organizational 
and market trust can yield great 
dividends for companies.

by Kevin Ash
Senior VP of Services, MasterControl

In the 2015 Edelman Trust Barometer, an annual trust and credibility study, the world’s largest public relations firm found that people’s trust levels in business fell in 16 of the 27 countries surveyed. The findings revealed that the people’s trust in business declined in two-thirds of the markets and now sits below 50 percent in the majority of countries – the worst showing since 2008.

Although the once-impenetrable technology industry remains the most trusted of all industry sectors (at 78 percent), declines across all tech-based industries were visible in the latest findings.

Needless to say, this widespread disintegration of trust is troubling for business.

May 6, 2015

The ISO 9001:2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.  
Prepare to jump on this change train!
by Robyn Barnes
Marketing Communications, MasterControl

ISO change is coming your way in the form of an ISO 9001 update.  This is a major revision to the standard and pharma companies need to prepare to jump on this train. 

Once the standard is published, companies will have a three-year transition period within which to comply.  Managers and other professionals involved in implementing, maintaining and auditing quality management systems are encouraged to be proactive and think about what they can begin doing now to achieve compliance with the revised standard.

May 5, 2015

Creating a High Performance and Low Risk Work Culture

The best articulated corporate vision and strategy 
is of no value if it cannot engage the hearts, minds 
and work habits of employees at all levels 
and convey a purpose beyond just profit. 
by David J. Patrishkoff
President, E3

Most of us have heard the phrase: "Culture eats strategy for breakfast." It could also be restated as "Your actions speak louder than your words." This means that management can dream up any strategy they want to but their behaviors and actions are what creates the culture of an organization, not their strategy. Culture drives the efficiency of an organization's processes. The culture drives the success or failure of an organization. The culture is the product of leadership decisions or the lack of decisions.

The mix of positive and negative forces present in any work culture fuels the cascades that drives success or failure of the whole organization. The best articulated corporate vision and strategy is of no value if it cannot engage the hearts, minds and work habits of employees at all levels and convey a purpose beyond just profit.