Regulations continue to evolve within the distribution arena of the Life Sciences industry. In particular, changes to the Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and <1083> Good Distribution Practices-Supply Chain Integrity.
Unfortunately, these increased demands do not come with clear guidance, which is putting additional pressure on companies to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
However, on a positive note, gathering sound data is not impossible. Companies putting in place more stringent measures to track temperature data are a healthy leap ahead of the rest of the industry and are reaping the benefits of being able to respond quickly to urgent site calls due to excursions as well as having access to generate fully compliant reports that can be used for regulatory submissions and inspections.
Increased data capture and compliance reporting can be approached as an opportunity rather than a burden. All the information to substantiate adherence to the regulations is there, ready to be converted into powerful tools to prove compliance.
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