The distribution and sales of illicit products such as counterfeit, unapproved and diverted medicines are a global concern for pharmaceutical patients, health care professionals, regulators and manufacturers. Counterfeit drugs are not equivalent to the genuine […]

Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual pharmaceutical company creates its own supplier assessment questionnaire. Suppliers routinely exhaust valuable resources continuously completing […]

Auditing to verify a process or system meet stated criteria.  The audit process involves looking for objective evidence that will substantiate that the process or system under review meets the objectives of the quality management […]

Although remote auditing has been in existence for quite a while the practice has become more prevalent and expanded with the recent onset of COVID-19. With public health or other emergencies that could cause risk […]

Supplier qualification audits and supplier technical visits are part of routine operations when working in the pharmaceutical or biotech industry.  Many times, technical visits and audits are confused with one another because there is some […]

The threats of intentional adulteration, cargo theft, counterfeiting, illegal diversion, and tampering are a serious problem in our global marketplace; where criminals are profiting by putting unassuming patients at risk. These threats are product integrity […]

Rx-360 through our Member Consortium has developed a Version 1.0 Best Practice Guide for Remote Auditing. This initial version will present a foundation on best practices that the Rx-360 membership have utilized and observed as […]

Pharmaceutical manufacturers and distributors frequently outsource various business functions to organizations that have a specialized expertise. While outsourcing can offer improved efficiency and cost savings, it also creates certain risks to product safety and security […]

The practice of tampering and re-use of original packaging represents a significant threat in the overall landscape of counterfeit and illicit drugs. A problem, which is growing and threatens the global pharmaceutical supply chain as […]

Counterfeit medicines are a serious and growing problem. Some estimates indicate that the global trade in counterfeit drugs approaches $200 billion per year. Globalization and the rise of eCommerce and B2B websites help to facilitate […]