The Pharma Report | Sept 2018

Introducing the newly formatted Technical Bulletin. It contains information to keep you appraised of new developments, inform you of emerging trends in science and regulatory news, as well as improve communication with our associates at DYNALABS.

SCIENCE CORNER

How are Potency Specifications Established?

Drug products that are designated compendial grade (USP; BP; JP etc), must meet specific requirements for quality. This article will clarify how to go about establishing quality requirements for potency testing.

Many companies rely on their contract laboratory to advise them on what the potency specification should be. However, the ultimate responsibility for establishing the acceptance criteria for a drug product rests solely with…

REGULATORY NEWS

FDA to Remove APIs from list

On August 28, 2018, the FDA announced via federal register notice, their intent to remove three active ingredients, Bumetanide, Nicardipine HCI, and Vasopressin, from the list of Bulk Drug Substances that can be used to compound drug products under section 503B of the FD&C act. The reasons stated for the removal were,…

PRODUCTS AND SERVICES

CQI Partner Program – Newly Revised and Expanded

DYNALABS is excited to announce the launch of our revised and expanded CQI Partner Program. This innovative and comprehensive new program is geared at helping our clients foster a culture of continuous quality improvement, by establishing the systems necessary to meet quality and regulatory requirements.

The program aims to achieve these goals by approaching them from both the side of DYNALABS and our clients. Every client that does business with DYNALABS has access to the products and services associated with this program, which include Production Systems, Improvement Systems, Laboratory Services, Data Analytics, and Consulting Services. We will be highlighting different aspects of the CQI Partner Program in future issues of The Pharma Report, so stay tuned!

For more information, please contact us at info@dynalabs.us, or click the URL below to learn more about the program.

TECHNOLOGY CORNER

21 CFR Part 11, Exceeding Standards

Over the course of 2017 and 2018, DYNALABS has invested hundreds of thousands of dollars, and increased its’ focus on data integrity, information security, and software validation processes. This will ensure we not only meet, but exceed, FDA standards for 21 CFR Part 11.

Additionally, we have made improvements to the DVx, our on-site testing solution, to support client growth, and to seamlessly execute future software updates through the cloud.

Lastly, we have begun working on improvements to our data structure and sample submission process, and are developing a new product configuration tool, that will increase both efficiency and accuracy of products submitted by our clients.

MARK YOUR CALENDAR

HCP
Health Connect Fall
October 1 – 3 | Los Angeles, CA – Booth #506 & 507

CSHP
California Society of Health System Pharmacists
October 4 – 7 | San Diego, CA
– Booth #101

IHFDA
International Health Facility Diversion Association
October 22 – 24 | Dallas, TX – Booth #10

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

WHO’S WHO AND NEW

Welcoming New Staff

We are delighted to announce that Lauren De La Cruz, MS has joined the DYNALABS team as a QA Specialist III in the Quality Department. Welcome aboard Lauren!

DYNALABS is also pleased to introduce our newest Senior Regional Business Manager, Kerri Botsonis BA, MA. Kerri will be managing the West Region. Welcome to the team Kerri!


Lauren De La Cruz	Kerri Botsonis

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.