Supply Chain Integrity Reduces Threats of Counterfeit Drug Products

In a recent Flash Report, Rx-360.org offered a summary of the proposed USP Chapter 1083 – Good Distribution Practices – Supply Chain Integrity.  In its report, Rx-360 noted that “globalization of all aspects of the pharmaceutical business has driven the need to address the threats of counterfeit or adulterated medication, devices and components, for which [...]

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 [...]

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 [...]

Drug Product Recalls Linked to Siliceous Flakes from Glass Containers

Glass is not inert and is particularly susceptible to chemical reactions at the surface. The glass formulation and manufacturing processes can influence the potential for leachables and/or glass flakes (delamination). The Na2O and K2O fluxes that are added to glass formulations reduce melting for forming glass but are weakly bonded and can leach into solutions contacting [...]