Rx-360 Launches Audit Sharing Program

West’s Andy Polywacz, Vice President of Quality, Americas, was recently quoted regarding the new Rx-360 Audit Sharing Program. According to a recent Rx-360 press release, the Audit Sharing Program collects and shares audits conducted by member companies on suppliers. Benefits of the program may include a broader “picture” of Quality Culture and performance and the [...]

Demystifying the Glass Blowback Feature In Pharmaceutical Container Closure Systems

Many folks in the parenteral drug business are confused about the blowback feature in glass and the no-pop ring on the elastomeric closures. Where did they come from? What are their function? What are the do’s and don’ts?  These package features are important to understand in order to select packaging materials and to avoid problems  [...]

Successful Audit Sharing Pilot Enhances Efficiencies In Supplier Audits

RX-360 is an organization composed of pharmaceutical companies and suppliers, working collaboratively to “create and monitor a global quality system that meets the expectations of industry and regulators that assures patient safety by enhancing product quality and authenticity throughout the supply chain.” Among the initiatives to achieve this goal, RX-360 is identifying efficiencies in the [...]

Glass Delamination Woes Trigger FDA Advisory

Recent additional product recalls due to glass delamination, including injectables such as dexamethasone, 23.4% concentrated sodium chloride for injection, bacteriostatic water for injection, potassium phosphates, sodium thiosulfate and sodium bicarbonate, have triggered an advisory from the U.S. Food and Drug Administration (FDA). The advisory is designed to help pharmaceutical manufacturers prevent glass flakes from forming [...]