Mar 5, 2015

3 Levels of SQF Certification

If you are interested in working in food safety, 
look into attending the SQF Certification program.
by Sam Lewis
Associate Editor, Food Online

SQF Certification is an assurance, assessment, and audit program that can increase your company’s marketability, domestically and globally.

The Safe Quality Food Institute (SQFI) operates under the motto of “One World. One Standard.” Its Safe Quality Food (SQF) Certification is the only one of its kind recognized by the Global Food Safety Initiative (GFSI) and is the only such program with a food-quality component added to its food-safety platform. SQFI’s goal is to utilize science-based, proven principles in order to consistently apply standards of food safety and quality on a global level. SQF Certification, recognized by all facets of the food-processing industry, is a measurement by which producers, suppliers, retailers, and consumers can be assured of safe, quality food products. SQF Certification virtually guarantees a higher degree of trust and acceptance in the global marketplace.

Mar 4, 2015

FDA Launches Drug Shortages Mobile App

FDA's new mobile app provides the public with 
rapid access to information on drugs in short supply.

by Christopher Kelly
FDA CDER Trade Press 

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”

Mar 3, 2015

After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

The med device industry and regulators continue working 
to promote practices that result in high-quality 
devices by focusing on manufacturing quality.
by Dan Matlis
Founder and President, Axendia

Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve product quality, compliance and the bottom line.

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).