Ensuring supply chain integrity today in the global market requires integrating risk management for a physical and a virtual supply chain. An approach that ensures supplier quality and performance and supply chain integrity is very important. The issuance of HR3204 Drug Quality and Security Act (...
Contract manufacturing organizations are our industry partners. There
are few strategic and tactical plans within the global life sciences that do
not include an outsourcing element. The maturation of the Indian and
Chinese markets has created opportunities to spread drug development,
...
Supply chains now span the globe and are increasing in complexity
as organizations move away from regional business models to
manufacturing and distribution on a world scale. A critical byproduct
of good manufacturing practice (GMP), an unbroken cold chain ensures
product safety, efficacy and ...
As we bid farewell to 2016 to face the opportunities and challenges of
2017, the global life sciences industry can be best described as being
on the cusp of great change. For the last ten years, U.S. market growth
has been transitory, with M&A activity defining the primary defensive
strategy to ...
Pressure and scrutiny from regulators, customers, and stakeholders continue to drive the pharmaceutical industry to search for alternate ways to produce quality medicines at reasonable cost.
Over a decade ago I wrote an article advocating that industry and FDA truly embrace the 2004 FDA guidance, which supported a shift from a documentation - and testing framework for assessing quality and compliance to one predicated on scientific understanding.