Companies which manufacture and distribute pharmaceuticals in domestic or international markets face more scrutiny than ever from regulating authorities, including the FDA and European Regulatory Authorities. Much of this scrutiny revolves around drug safety, also known as pharmacovigilance.
Appropriate and effective risk management and supply chain safety and security protocols are vital for FDA and EU compliance. There have been many highly publicized instances of adverse drug reactions and interactions and regulating authorities are demanding more and more from pharmaceutical companies in order to attain and maintain compliance over the lifecycle of a product.
Understanding the Globalization of the Supply Chain and Regulatory Changes
Government regulations and the widespread availability of distributed manufacturing mean that sometimes it's simply more cost effective to produce pharmaceuticals, medical devices and other life sciences products overseas. The practice is so prevalent that in late 2013, President Barack Obama signed the Drug Quality and Security Act (DQSA) into law specifically to provide for better tracking of where prescription drugs originate.
This law makes things a bit more complicated for manufacturers, repackagers and distributors of pharmaceutical products. Over the next decade, these companies must implement systems for detailed electronic product tagging, product tracing, product verification, quarantine measures for suspect drugs and a host of other provisions.
The Task of Remaining Compliant
The FDA is still in the process of developing specific guidelines. Nonetheless, the scope of the initial act seems to indicate that new regulations will be broad.
For instance, the FDA notes that Title II of DQSA was motivated primarily by the threat of supply-chain-specific risks like cargo theft and counterfeiting. For pharmaceutical and device manufacturers to combat such problems, which are arguably beyond their regular jurisdictions, they'll likely have to implement a significant number of new controls.
Read this article to gain insight on how some firms in the medical devices industry are supplementing their operational capabilities in order to cope.
Pharmacovigilance Mitigates Risk
Supply-chain pharmacovigilance may be critical to regulatory compliance, but it's also essential to public relations as it relates to your brand. Firms that take proactive steps to secure their supply chains and manage and mitigate their risks will undoubtedly produce superior products. In doing so, they can avoid the serious damage to reputation and major legal and financial ramifications that often come with medicinal product issues..
Comprehensive supply-chain security actions may also make it easier to conduct business on an international level with new products. Codes like ISO 13485, ISO 9001 and FDA 21 CFR 820, 210 and 211 undergo constant transformations, and supply-chain security may soon become an integral component of these gateway standards. Implementing compliance controls now is key to keeping up with future changes as they occur.
For help with your compliance challenges, contact GxP-CC. This team of experts will help you initiate the right supply chain management strategy to mitigate your risks both pre-and post-production.