Category: Qualification and Validation

Just a tiny refresher… are you approving suppliers and customers appropriately? We posted about this topic before, as it is business and licence critical. Bona Fides (Approval of Suppliers and Customers) Checks – how and why? Suppliers and customers are on either side of you in the supply chain, and if you supply someone who…

Are your suppliers and customers validated or bona fide? bona fide ˌbəʊnə ˈfʌɪdi/ adjective 1. genuine; real. “she was a bona fide expert” Synonyms: authentic, genuine, real, true, actual, sterling, sound, legitimate, lawful, valid, unadulterated, legal unalloyed, proper, straight, fair and square. Bona fides checks are a critical piece of the GDP puzzle. Within the EU Guidance 2013/C 343/01 the term “bona fide” is not used, however this…

For those of you who are not aware EUDRAGMDP is the new, centralised depository for the National Competent Authorities in Europe for manufacturing, import and wholesale distribution authorisations, and GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) certificates. The public version of the EUDRA GMDP database is a useful tool for anyone involved in…

The MHRA are still issuing the new WDA(H) to licence holders, and after the next inspection cycle all licences and GDP compliance certificates will be found here; http://eudragmdp.ema.europa.eu/ The site allows you to search by WDA number, address and more. You are now responsible for ensuring that anyone you outsource work to is compliant, and…

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