Feb 26, 2015

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple 
reasons to consider automating SOP management.

by David R. Butcher, Marketing Communications, MasterControl

To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

Companies across all industries use standard operating procedures to minimize potential for miscommunication and to operate safely and more efficiently. Development and usage of SOPs are a key part of any successful quality system, as they provide employees with the information necessary to perform their jobs properly while facilitating consistency in the quality of processes and products.

Feb 25, 2015

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling 
your compliance efforts? Learn how 
to fix seven common document 
management mistakes.
by James Jardine

Marketing Communications, MasterControl

Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

Inefficient Manual Paper-Based Systems
Managing documents manually simply perpetuates a wasteful system that is prone to error. Plus, manual document management systems are often responsible for introducing quality problems that can result in product defects and regulatory penalties. And don’t fool yourself into thinking you’re any better off with that hybrid paper/electronic system you’ve Frankensteined together. It’s just as inefficient.

Feb 23, 2015

FDA Issues New Draft Documents Related to Compounding of Human Drugs

FDA has issued five draft documents related to 
drug compounding that are applicable to pharmacies, 
federal facilities, outsourcing facilities and physicians.
From U.S. Food and Drug Administration

The U.S. Food and Drug Administration has issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions. The draft documents are applicable to pharmacies, federal facilities, outsourcing facilities and physicians.

The new category of outsourcing facilities was created under the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013 in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

Feb 19, 2015

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

by David R. Butcher, Marketing Communications, MasterControl

An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

Feb 18, 2015

Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Are you familiar with the draft guidance 
on GMPs for combination products?
by Suzanne M. O'Shea
Counsel, Faegre Baker Daniels LLP

Two years ago, in January 2013, FDA published the final regulations on Good Manufacturing Practices for Combination Products.[1]  These regulations are built on the concept that the constituent parts of a combination product retain their regulatory identity as a drug, device, or biological product, even after they are physically, chemically, or otherwise combined into a single-entity combination product (i.e., prefilled injector or drug eluting stent) or co-packaged together.[2]  Therefore, all the good manufacturing requirements associated with each constituent part must be complied with in the manufacture of single-entity and co-packaged combination products. 

Feb 17, 2015

The Perks of Pursuing a Career in Quality Management

Don't fear the auditor!  Instead, become one!  Auditing can 
lead to a variety of career paths in an organization.
by Greg Peckford
Founder, Quality Career Advancement

It is a bit of a mystery to me that more is not made of the personal career advantages and knowledge gained from performing procedural assessments, audits and other quality management related functions. For me personally, this type of activity has been one of the key factors in my career progression and advancement.

Feb 12, 2015

Success By the Numbers (or Why Being Science-y is a Good Thing)

Executive Vice President, Operations

How do you know if you know? In other words, how do you know when you have sufficient knowledge to reliably manage or improve a process? This last question reveals the foundation of all quality, regulatory, and compliance work.

More than a century ago, Lord Kelvin suggested a simple touchstone to answer this crucial question:
"When you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot express it in numbers, your knowledge is of a meager and unsatisfactory kind.  It may be the beginning of knowledge, but you have scarcely, in your thoughts, advanced to the state of science."

Feb 10, 2015

FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

COO, VTS Consultants, Inc.

If there is one word within the life science industries that causes concern and anguish it is “audit.” As with any evaluation process, the success of getting through a regulatory audit is a combination of preparedness with regards to what to expect, knowing the current regulations that apply to your product and knowing what tends to be the areas of deficiencies in audits  performed. All of these items can be researched on the web and the time and effort to review and provide training on them will serve companies well.

Feb 5, 2015

CAPA Should Not Be a Dreaded Four-Letter Word

A poorly maintained paper-based CAPA 
process may contribute to FDA violations.
by Cindy Fazzi
Editor, MasterControl Insider

In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.

Some organizations think of CAPA only after quality issues have emerged. Others have CAPA systems in place but they are inadequate. This is evident in the case of a medical device firm, which received an FDA warning letter. Among other things, the agency said, “your CAPA implementation is inadequate in that you do not trend component failures” (1).

Feb 4, 2015

Murray Explains ISO 9001 Update at MD&M West

Walt Murray makes learning about 
ISO 9001 updates interesting. Don't miss 
his MD&M West presentation!
by Robyn Barnes
Marketing Communications, MasterControl

MasterControl's Walt Murray will address MD&M West attendees at 2:00 PM Tuesday, February 10 in Anaheim, California.

Murray is a frequent MD&M West speaker who is a recognized authority on ISO 9001.  He's authoritative and entertaining, so this is a session you won't want to miss.

Murray will be part of a panel discussing the topic “Building Robust Risk Management.” His presentation, “ISO 9001 2015 Update: Implementing More Effective Risk Management” is timely, considering the transition that will be required of companies when the new standard is published in 2015.  He’ll discuss the new requirements for review, documentation updates and risk management; analyzing outcomes as a result of risk management changes; and explore the more risk-driven approach to actions to address risk.

Feb 3, 2015

Measuring Risk Management Outcomes

Director, Paladin Risk Management Services

In his book Decision Making: Risk Management, Systems Thinking and Situation Awareness, Dr Alan McLucas introduces the concept of the Risk Management Paradox:
“The task of managing risks effectively is confounded by a classical paradox.  That is, if risks are being effectively managed as a matter of routine, there will be very few surprises.  Nobody becomes aware of just how effective careful risk-management actions have proven to be.  Nobody slaps the manager on the back and congratulates them for a job exceedingly well done.  In stark contrast, however, if risks are managed poorly, the whole world lines up to say so.