EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use
The EU Commission has published a new Draft Guideline on Good Distribution Practice. This new takes into consideration the regulations of the Directive on Falsified Medicines and should replace the existing regulations which have been valid since 1994. What this implies for the pharmaceutical wholesale can be read here.
News IPEC-Americas "Distributors Audit Guide" for Pharmaceutical Excipients
IPEC Americas has published a new Distributors Audit Guide. The document was developped to support audits of API suppliers and their supply chain. European standards from the "Good Distribution Practices" and from the WHO were taken over. Read more here