In a recent Blog post I discussed two recent regulations that were introduced last year, one for GDP (Good Distribution Practices) within the EU and one for GSP (Good Supply Practices) within China.
When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.
On November 27th of 2013 when President Obama signed into law the HR3204 - the Drug Quality and Security Act, it was the result of many years of discussion and past attempts to establish a US centric law based upon securing the drug supply chain in an effort to prevent the entry of falsified medicinal products into the supply chain.
In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).
On January 17th, 2014, the World Health Organization (WHO) confirmed that they had completed their testing of the DeltaTrak FlashLink Certified Vaccine Data Logger with Glycol Bottle and this product was now prequalified to be included in its list of recommended products.
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