Regulatory requirements are increasing all the time in life sciences, and recently it has seemed as though the rate of release of new guidelines and directives is accelerating.
Beyond the authorities’ need to set new standards to safeguard patients, there is a growing market expectation for transparency around everything that is happening within a company and along the supply chain. All of this is creating more red tape for the industry: demands that must be serviced and managed. The more rules there are, and the more frequently these change, the greater the risk of something going wrong. Similarly the more products, variants and markets a company is dealing with, and the shorter the release cycles, the greater the controls needed across documentation, packaging and labelling to ensure nothing slips through the cracks.
Companies rarely get off lightly if they fall foul of regulations, which could be something as simple as failing to spot a misprint until it’s too late, or neglecting to meet new guidelines in a given market...
This article is taken from PharmaExec.com, June 2016