The Society of Quality Assurance is dedicated to promoting quality in the regulated research community, including clinical settings, laboratories, and manufacturing facilities. This year the annual meeting, held March 26-31, boasted attendance of over 800. Located in National Harbor, Maryland, the conference was in close proximity to Washington DC, posing a unique opportunity for more than 26 representatives from the FDA regulatory agencies to attend. A significant number compared to years past.

The team at T3 Labs takes great pride in our 21 CFR Part 58 GLP compliance program for preclinical testing. Since innovation, policy and regulatory changes breed a constant flow of new regulatory guidelines, T3 attends SQA so that our team fully understands the best practices, operating procedures, and current regulatory policies.

Here are are a few of the highlights and insights from SQA 2017, courtesy of Director of Quality Assurance for T3 Labs, Kenneth Zielmanski: an 11-year member of SQA.

The FDA’s hard pressed effort to revise the GLP regulations

Medical product innovators and organizations have for ~3 years been awaiting the pending approval of a revision of the FDA Code of Federal Regulations ( 21 CFR Part 58) that governs GLP for conducting nonclinical laboratory studies. The Society of Quality Assurance issued a 55 page brief commenting on each proposed article made in the revision. In short, the overwhelming majority of SQA members seemed to suggest leaving the regulations as they are.

As of January 21, 2017, the comments have been submitted and the FDA is now in the evaluation process. The society is eagerly awaiting the final version of the revisions to GLP standards to be released soon.


SQA reporting good news regarding GLP compliant labs all over the Country

Representatives from the U.S. Department of Health and Human Services, the U. S. Food and Drug Administration, CDRH and other regulatory bodies give seminars, lectures and participate in panel discussions on the latest in compliance at SQA including issues they have found visiting other CROs. There have been 110 GLP audits conducted in 2016.

There are three categories of scores that a GLP compliant lab can attain during audit- “NOI-No action indicated,” “VOI-Voluntary action indicated,” and “OAI- Official action indicated.” Of the 110 GLP audits this year, 46% have received a score of no action indicated with 54% were in the category of voluntary action indicated. This improvement in the percentage of labs that were successful in audits implies that organizations understand these regulations and are complying.

Since all three of the past three regulatory T3’s audits have resulted with no action indicated, in the eyes of the regulators, our lab practices are in compliance.

“The facilities are top tier. We designed the facilities to make it easy to move from concept through protocol to budgeting and now it happens as efficiently as possible.” – Dr. Robert Matheny, MD, Chief Scientific Officer of CorMatrix Cardiovascular Inc.

From the FDA- make sure your data matches your protocol

At the end of the day, GLP and the SQA is all about the safety of the product as it moves through the developmental pathway. We write and execute preclinical testing approval protocols for devices and products that will eventually improve healthcare. For individuals doing research and providing protocols and other documentation to the FDA, it is very important to review your data- the data collection should match the requirements of the protocol.

Surprisingly there are many submissions where the raw data does not match the approved protocol requirements. This is a source of  wasted time and treasure which can be lethal to small medical device companies. That is why having a highly qualified preclinical partner is of high value. Based on our extensive GLP experience, we understand what the sponsor is looking for, what the regulatory body requires and and we gather the precise raw data needed as efficiently as possible.

“T3 Labs delivers thorough GLP reports that generate regulatory clearances as swiftly as possible which is immensely valuable to us.”- Bryan Pinchuk, Project Manager at Surefire Medical

See you next year at SQA 2018!
Ensuring we remain on the forefront of the latest FDA requirements and take every opportunity to learn from the experience of our peers is all the reason we continue to invest in the SQA Conference every year.

Are you an innovator seeking a quality preclinical partner to help guide you through the regulatory process from concept to cure through preclinical and ultimately commercialization? Want to learn more about our AAALAC certified and GLP compliant services? Contact us today!