The Pharma Report | Nov 2018

Case Study 4: The Mystery of the Disappearing Fentanyl

It is never convenient when the test result for a product, that has historically been within specification, comes back with an Out of Specification (OOS) result. It is however, critically important for safety, regulatory, and economic reasons, to determine what is causing an OOS result. The time and resources required to determine the root cause for a failure can return valuable, and sometimes surprising results. “The Mystery of the Disappearing Fentanyl” is one of those situations. What was originally thought to be a testing issue, turned out to be something entirely different, and enlightening.

REGULATORY NEWS

FDA Guidance on Container Closure Systems (CCS) and Out of Specification Investigations (OOS)

“The Mystery of the Disappearing Fentanyl” case study highlights the potential impact of the container closure system on a final drug product, and the importance of having a comprehensive and robust investigation process.

To minimize issues associated with a specific CSS, a firm must go through a qualification process to determine the “Suitability” of a container closure system with their drug product. A CCS is deemed suitable only after…

PRODUCTS AND SERVICES

Container Closure System (CCS) Suitability Services

A proactive and comprehensive strategy for qualifying and selecting CCS’s that are compatible and adequately protect your products is essential. Discovering that the active ingredient has an affinity to one of the components of the CCS, or the CCS does not protect the product from light, water, air or microbial intrusion, or causes the active to degrade, or has an extractable or leachable substance that is harmful to the patient or interferes with the testing methodology, is not something a firm wants to discover during an expensive and time consuming stability study, or just prior to launching product to the market. Whether you are at the beginning of the process of selecting a CCS, or you have a product in the market or that is ready to go to market, contact us today about our CQI Partner Program “Component Qualification” services. We will work with you to design a comprehensive and cost-effective program to qualify new and existing CCS’s.

For more information, please contact us at sales@dynalabs.us to learn more about the program.

TECHNOLOGY CORNER

Updates; OOS, Password Security

Updates to DYNALABS Out-of-Specification (OOS) Investigation Reports

The investigation reports are being updated to be compliant with 21 CFR Part 11. Completed reports will be electronically signed by our Quality Department and will be made available on myDYNALABS Sample Tracking Application. In addition to providing signed completed reports, all In-Process OOS Investigation Reports will be available for download from the same application. These In-Process Reports will have a watermark and will not be signed.

Updates to DYNALABS Password Security

To increase security, access to the website will be denied after 5 incorrect attempts to login. The User will be locked out until contacting their Customer Service Representative.

Storage Fees
Sample storage fees will be changed from a flat fee of $350 per study to $1 per lot/day with a minimum charge of $100/study. If a study is currently in-process, it will not be affected. Effective as of June 1st, 2018.

MARK YOUR CALENDAR

ASHP Conference
American Society of Health-System Pharmacists
December 2 – 6 | Anaheim, CA – Booth #910

DYNALABS will be closed on these days:
11/22/18-11/23/18 – Thanksgiving. We will resume our normal business schedule Monday 11/26/2018.

Please make all the necessary shipment arrangements to have the samples arrive on or before Wednesday 11/21/2018 or on or after Monday 11/26/2018.

12/24/18-12/25/18 – Christmas. We will resume our normal business schedule Wednesday 12/26/2018.

Please make all the necessary shipment arrangements to have the samples arrive on or before Friday 12/21/2018 or on or after Wednesday 12/26/2018.

12/31/18-1/1/19 – New Years. We will resume our normal business schedule Wednesday 01/02/2019.

Please make all the necessary shipment arrangements to have the samples arrive on or before Friday 12/28/2018 or on or after Wednesday 01/02/2019.

WHO’S WHO AND NEW

DYNALABS is happy to announce:

Recent Promotions of:
   DJ Ballance-Weichman has recently been promoted to Sample Management Lead
   Alexis Brown has has recently been promoted to Microbiology Analyst II
   Marcia Sena has recently been promoted to Validation Chemist I
   Easton Noble has recently been promoted to Chemistry Analyst I
   Lauren Salvagno has recently been promoted promoted to Chemistry Analyst III

The addition of John Weber as a Customer Support Specialist for our expanding National Accounts. John graduated with a Bachelor of Arts in Biology from University of Missouri – St. Louis.

The addition of Jeremy Knutson as the Metrology Supervisor. Jeremy graduated with a Bachelor of Science degree in Chemistry from Bemidji State University in Bemidji, MN.

IN THE NEWS

DYNALABS Named One of the Nation’s Fastest-Growing Inner City Businesses

The Initiative for a Competitive Inner City (ICIC) announced that DYNALABS has made the 2018 Inner City 100 list of the fastest-growing inner city businesses in America. This is the second time that DYNALABS has earned this award. ICIC is a 25-year-old national nonprofit founded by Harvard Business School professor Michael E. Porter.

DYNALABS LLC is registered with the U.S. Food and Drug Administration (FDA), the DEA and Bureau of Narcotics and Dangerous Drugs, as well as ISO 17025 accredited. The products and services provided by DYNALABS are protected by U.S. Patent Nos. 7,197,405 and 7,660,678.