News

FDA Orders First Mandatory Recall of Its Kind

The Food and Drug Administration ordered a mandatory recall of a powdered herbal supplement, kratom, on Tuesday. Dietary supplements are classified as foods under federal law, making the recall the first-ever mandatory recall of a contaminated food. The FDA obtained...

Clarke Solutions Will Exhibit at Interphex 2018

Fishers, IN – Clarke Solutions, an industry pioneer in providing field-tested services in packaging, automation, validation, and serialization, will be exhibiting at the Interphex 2018 trade show at the Javits Center in New York City from April 17-19, 2018. In Booth...

ISPE Packaging Validation Discussion Paper

By Erica Stolz The International Society for Pharmaceutical Engineering (ISPE) recently published a new Packaging Validation Discussion Paper.  The paper is intended to help bridge a gap spanning between manufacturing process validation and packaging process...

4 Steps to Successful FDA Change Management

By Vonda Ashley Change management is one of the key elements to a quality system in the pharmaceutical industry. Most pharmaceutical companies understand the need and purpose for change management as an overall concept and have a system(s) already in place to manage...

How to Streamline User Requirements

By Laura Reeve Reading and deciphering requirements in a wordy URS can be frustrating and cause complications for OEMs.  Clarke has generated a streamlined URS format that helps eliminate unnecessary words and uses an outline/indented format to present specific...