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Dec 31, 2013

An Argument for Effective Quality Management Systems

Kamaal Anas

by Kamaal Anas, Vice President Regulatory Affairs, Wright Medical Technology

All too often, quality management systems are seen as a cost of doing business – a requirement of regulators (e.g., 21 CFR 820), customers (e.g., ISO 9001:2008) or overbearing parent companies – rather than as a tool for management to effectively manage their organizations.  However, quality management systems that are effectively designed, implemented, utilized and continuously improved upon provide management with quality information, delivered in a timely fashion, which facilitate data-driven decision making.  Designing and implementing a quality management system that provides the appropriate information for management to make educated decisions requires careful thought and detailed planning.  Once accomplished, management will have the tools to effectively allocate resources to risk-prone areas and reduce the cost of poor quality.

Industry Backdrop

There are three proverbs/curses, attributed to the Chinese, that are applicable to many regulated companies, (1.) May You Live in Interesting Times, (2.) May You Find What You Are Looking For, and (3.) May You Come to the Attention of Those in Authority.



Dec 23, 2013

How to Confuse and Confound Your Trainees in 10 Easy Steps!



Jill Drummond

by Jill Drummond, Director Training  Education, Blood Systems

On-the-job training is usually conducted one-on-one or in small groups so it can be challenging to confuse trainees; but fear not — when employees start a new job, they are usually a little nervous or apprehensive.  They want to make a good impression and they want to be successful in learning their new tasks.  This is when they are most vulnerable and they are easy pickings for total confusion.  Follow these simple steps and you will have your new hires running for the hills and totally flabbergasted and ineffective in their jobs. 

Dec 18, 2013

10 Guidelines for Writing Superior SOPs


Robyn Barnes

by Robyn Barnes, Public Relations Specialist, MasterControl Inc.

Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value.  Using the following 10 guidelines, you can create a successful SOP document.


Dec 12, 2013

Biosimilars Establishing Themselves in Europe


Peter Calcott

by Peter Calcott, President, Calcott Consulting LLC.

From the introduction of the Guidelines for Biosimilars in the EU in 2004, Europe has been pressing hard for the introduction of these money-saving options into the marketplace.  The initial guidelines of 2004 were followed very rapidly with further guidances on comparability (2005), preclinical and clinical requirements (2005), recognition of the changing landscape (2010) and in 2011, further recommendations for studies and statement of the recognition of the issues surrounding licensure.  To aid developers they even issued product specific guidances, recognizing that each molecule would have specific challenges to overcome.  From the issuance of the first two in 2005 for granulocyte colony stimulating factor (GCSF) and human somatotropin, to interferon beta, follicle stimulating hormone and insulin in 2011, we have seen others in the intermediate period including epoietin, heparin, interferon alpha, and monoclonal antibodies (MoAbs).

The activity has not been simply issuance of guidances and guidelines, but actual approval of products, with them well-established in the market place. The first approval for human somatotropin was for Sandoz’s and BioPartners’ versions with the latter withdrawn by the manufacturer later.  We have seen various epoetins, filgrastims (GCSF) and follicle stimulating hormones with a total of 18 approvals with 2 withdrawals through 2012.


Dec 10, 2013

A Risk-Based Approach to Validation




Peter Knauer

by Peter Knauer, Partner Consultant, MasterControl Inc.

FDA classically has defined the requirements for validation under 21 CFR 820 and 210/211 regulations as a comprehensive testing process where all systems are given thorough examination and tested under equal weight, complete with an exhaustive evaluation process. Recent guidance and initiatives by FDA (Process Validation: General Principles and Practices) and ICH (Q11: DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES) have provided a streamlined risk based approach under an updated life cycle management methodology. Under this scenario, a new definition of validation has emerged, best described by FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products.” This is in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75:

“Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.”

What this means is that a risk-based life cycle management approach with relevant scientific rationale and evidence can be used in lieu of a traditional top-down comprehensive approach. Many of us remember the golden rule of validation; triplicate test runs as an output of this classic approach. It didn’t matter the complexity or simplicity of the system, just always apply the test in triplicate. Essentially what FDA and ICH are now saying is that if you can justify a different test plan with a risk-based approach, it is fine with them. The end result is that many validation processes can be streamlined and production delays eliminated. Below is essentially a discussion on the ‘best practices” approach I have successfully used to meet these updated FDA and ICH guidances.



Dec 5, 2013

What If You Needed SOPs to Run Your Household?




Laurie Meehan

by Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.


In August, I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s Digital Summit.  The presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into much more detail than our February blog post on the same subject (which you can read here: http://bit.ly/YGTQWd).

Rosanne Sylvia-Heeter, Director of cGMP Compliance at Polaris, is always chanting the
FDA compliance mantra, “If it’s not documented, it didn’t happen.”  As I worked on the blog post with her last winter, I was struck by the amount of documentation actually needed to comply with 21 CFR Part 111 distribution regulations.  As we worked on the Digital Summit presentation this summer, I was struck by something else.  In the course of simply maintaining a residence, members of my household actually perform a lot those Part 111 activities.  And so do yours.

The big difference is that we don’t have to write it all down.