Regulatory Archives

Intermountain Healthcare Improves Sterile Compounding Services with RIVA Systems

Posted on October 25, 2018

In the wake of market and regulatory changes several years ago, Intermountain Healthcare, one of the most respected health systems in the United States, identified an increased need for controlled sterile compounding preparations. This need was heightened by the New England Compounding Center tragedy, as it raised additional concerns about risk and lack of control... Read more

New NAPRA Compounding Standards

Posted on July 21, 2016

By: Irene Wasilewski, Application Consultant What is NAPRA? The National Association of Pharmacy Regulatory Authorities (NAPRA) is a voluntary association of Canadian provincial and territorial pharmacy regulatory bodies as well as the Canadian Forces Pharmacy Services. NAPRA members regulate the practice of pharmacy and operation of pharmacies in their respective jurisdictions in Canada. Their primary... Read more

A Breath of Fresh Air

Posted on December 3, 2015

By: Mitch Valdmanis, Senior System Designer Part III: Of Pass-through Chambers and Control Systems In parts I and II of this series we described how RIVA has been designed to achieve ISO level 5 air cleanliness by sealing the compounding chamber, filtering incoming air, and maintaining laminar airflow inside of the cell. So far so... Read more

FDA issues new guidance for dispensers covered under the Drug Supply Chain Integrity Act

Posted on July 29, 2015

By Nancy Panos The product tracing requirements in sections 582(d)(1) of the Drug Supply Chain Integrity Act took effect for dispensers July 1. However, some dispensers had expressed concern that electronic systems used to exchange, capture and maintain product tracing information would not be in operation by the effective date. But in a July 1... Read more

Automated compounding enhances safety and regulatory compliance

Posted on July 2, 2015

By Niels Erik Hansen, Ph.D. In January, the Department of Health and Human Services’ Office of the Inspector General (OIG) issued a report about hospitals’ use of standalone compounding pharmacies to produce compounded sterile preparations (CSPs). The study was spurred by concerns about the quality of CSPs following the 2012 meningitis outbreak caused by contaminated... Read more

RIVA automated compounding technology supports PIC/S-compliant production for compounding centers and hospital pharmacies

Posted on February 4, 2015

by Thom Doherty Businesses providing regulated aseptic compounding services require stringent quality control measures, and good manufacturing practices (GMP) provide the framework for implementing critical quality control processes. Automation, which provides unparalleled product and process repeatability, is increasingly seen as a solution for compounding centers and hospitals to meet the requirements of highly-regulated manufacturing environments. Read more

Categories: Automation | Blog | Regulatory | Safety

The Importance of Intellectual Property Management

Posted on February 2, 2015

by Christine Ross Intellectual Property (IP) is one of the most important assets of a leading edge technology company. Whether it be patents, copyrights, trademarks, trade secrets or know-how, it is critically important to identify it, document it, protect it and in some cases, register it. All of this activity takes a team of engineers,... Read more

Rewards and Frustrations of SQA

Posted on October 8, 2014

By Vladimir Shterenberg Software quality assurance (SQA) and testing can be as rewarding as it can be frustrating. Every organization has different ideas on what quality means and what level of quality is needed for their products. You would think the highest quality possible would be the universal answer, but when it comes down to... Read more

Protection of PHI – Why we must pay attention to the internal threat.

Posted on August 11, 2014

By Christine Ross A few years before Canada and the USA had enacted privacy legislation, I was working at an IT services company as a software developer customizing, implementing and supporting patient management systems for hospitals. I had been with the company for a couple of months when my director stopped by my desk to... Read more

Recent Regulatory Actions: Focus on Quality in Compounding

Posted on August 6, 2014

by Craig A. Boyce , RPh Over the past month, a number of regulatory changes have occurred surrounding aseptic and sterile compounding. Some of the significant regulatory actions include: FDA release of the cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (7-1-2014) Massachusetts passage and signing of... Read more