The Importance of Applying Risk-based Design Control to Process Validation

Design transfer continues to be a major
cause of quality problems. 
Walt Murray
will address this regulatory 
In order to have a successful submission for approval of drugs, medical device, biotechnology, supplements, combination product and IVD an organization must have a prolific and structured design process. According to regulators, this process must now include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.

In ISO 13485:2016, for example, a new design and development transfer subclause was added (7.3.8), stating the organization shall document procedures for transfer of design and development outputs to manufacturing. These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements. Results and conclusions of the transfer shall be recorded. This makes explicit the input of manufacturing into design considerations.

MasterControl quality and compliance expert Walt Murray will be addressing this new regulatory development at INTERPHEX, to be held April 26-28 at the Javits Center in New York City, New York. His session, titled “Establishing Design Parameters to Validate Final Product Specifications Using a Risk-based Phase Design Control Approach,” will explore and explain the process and caveats necessary to be successfully compliant and execute product specifications with minimal risk, good change control and process design control.

This article is related to the White Paper:
ISO 13485 - Change? Do I Have to??
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“Design transfer continues to be a major cause of quality problems,” according to Murray. “You cannot just throw a design over the wall to the next department and hope for best. Now, regulators expect—no, they require—that manufacturers ensure that the product design is correctly translated into production specification, and then repeatedly and reliably produced within product and process capabilities. This is challenging.”
Murray, who is slated to speak April 27 at 2:15 p.m. EST, hopes attendees will walk away from his session able to do four things: establish a new gate-phased risk-based approach to process validation, understand the review component used in each phase, develop an integrated risk-based approach that is simple, and create visibility using critical thinking as the basis for establishing data and information.

Quality-by-Design (QbD) over time has evolved into a snazzy catch phrase for any condition which stipulates that any capture of information is sufficient to justify this concept,” says Murray. “To the contrary, QbD is a set of design processes for the explicit conversion of information/documentation using good critical thinking skills. The competency for the application of these skills are as important as the compilation and evaluation of sound facts. I hope to show attendees that inference from expertise should be used in conjunction with factual data to validate risk-based decisions.” 

Walt Murray is a quality management and regulatory affairs professional with more than 32 years of experience working with internationally recognized, highly regulated companies, including Aventis-Pasteur, Merck, Pfizer, Stryker, USANA and Del Monte Foods.  A Six Sigma Black Belt, Murray is certified in quality and environmental systems auditing (AQS Systems), critical-thinking skills and process control.  He also has extensive training and consulting expertise in quality event/CAPA management, risk management, supplier control and audit management.

Having personally performed more than 200 third-party audits, for a variety of Fortune 500 life sciences companies, Murray has hosted investigational and systems audits by the FDA, Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA) and Health Canada.

Lisa Weeks is a marketing communications specialist at MasterControl Inc., writes extensively about technology, the life sciences industry, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.