A Pharmacovigilance audit is important as it ensures the company’s drug safety and risk management procedures comply with applicable laws, regulations and guidance. While it could be a daunting challenge at times to comply with the existing regulations, companies, large and small, still must deal with this reality as the organization’s entire business operations could not be put to risk of failing an audit or inspection.
This paper looks at the challenges specific to Asia and recommends 6 practical tips to be taken into consideration to implement risk management, audit, inspection and adverse drug reaction management strategies whilst complying to regulatory requirements.