by Marci Crane
INTERPHEX, one of the largest trade shows and combined fairs and exhibitions for the pharmaceutical, biosciences, biotechnology, medical device, and biomedical engineering industries was held last March at the Javits Center in New York, New York. There are 10,000 participants expected every year for INTERPHEX and 2016 was no exception.
“INTERPHEX 2016 was a resounding success for both exhibitors and attendees alike who hailed from 52 countries around the world and 48 states across the U.S.,” said Ed Several, Senior Vice President, INTERPHEX. “This year’s INTERPHEX once again succeeded in bringing together inspired professionals with key industry leaders to share knowledge and best practices, as well as see the latest cutting-edge technologies needed to cost-effectively develop and manufacture quality products.”
MasterControl’s Walt Murray presented a featured session at INTERPHEX titled "Establishing Design Parameters to Validate Final Product Specifications Using a Risk-Based Phased Design Control Approach."
According to Murray, “For 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. The process must include the explicit condition of technical transfer as a formal review step to manufacturing/assembly.”
To get the full details, please view the free webinar.
Murray's main learning objectives for INTERPHEX attendees throughout his presentation included the following:
1) Establish the new gate-phased risk-based approach.
2) Understand the review component used in each phase.
3) Develop an integrated risk-based approach that is simple.
4) Create visibility using critical thinking as the basis for establishing data and information.
Murray also reminded INTERPHEX attendees what QbD is supposed to accomplish when he said, “QbD over time has evolved into a snazzy catch phrase for any condition which stipulates that a capture of information is sufficient to justify this concept. 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. Also, inference from expertise should be used in conjunction with factual data to validate risk-based decisions.”
Throughout his presentation, Murray discussed the design control process, the evaluate risk and controls processes, and internal processes, using practical scenarios designed for attendees. He also reviewed guidance from ICH Q8(R2) and discussed the opportunities that exist to develop more flexible regulatory approaches, for example, to facilitate:
- Risk-based regulatory decisions (reviews and inspections)
- Manufacturing process improvements, within the approed design space described in the dossier, without further regulatory review
- Reduction of postapproval submissions
- Real-time quality control, leading to a reduction of end-product release testing
- Defining the quality target product profile (QTPP) as it relates to quality, safety and efficacy, considering e.g., the route of administration, dosage form, bioavailability, strength, and stability
- Identifying potential critical quality attributes (CQAs) of the drug product, so that those product characteristics having an impact on product quality can be studied and controlled
- Determining the critical quality attributes of the drug substance, excipients, etc., and selecting the type and amount of excipients to deliver drug product of the desired quality
- Selecting an appropriate manufacturing
He went on to discuss defining a control strategy, control planning, risk-based verifications, process areas, and additional compliance standards.
To receive Murray's presentation slides from the 2016 INTERPHEX conference, please contact Marci Crane at email@example.com.
Marci Crane is MasterControl’s localization manager and a marketing communications specialist. Marci writes on topics related to localization and knowledge leadership within the life science industries and other highly regulated sectors.