New IPEC GDP Audit Guideline Document
EU GDP Inititives
New Regulatory Updates
European Commission has issued the new GDP Guidelines. The revised version includes extensive changes to the current version with many new additional requirements impacting wholesalers and distribution companies. Key changes include addition of the requirement for auditing of the contractors, self inspection programs, documentation practices.
IMB issued New GDP Guideline for Wholesalers.
New pharmacovigilance legislation changes apply from 2 July 2012 for products authorised via the Centralised procedure, and from 21 July 2012 for Mutual Recognition/Decentralised and National procedures
On July 1st 2011 The European Directive 2011/62/EU ("the Falsified Medicines Directive") introduces measures to prevent the entry of falsified medicines into the legal supply chain. In very general terms the Falsified Medicines Directive, MHRA has just published a useful Q&A, see details
The IPEC has just launched its newly revised Good Distribution
Practice (GDP) Audit Guideline for Pharmaceutical Excipients. The new document is designed for auditors
evaluating the practices and quality systems of distributors who sell, store or
repackage pharmaceutical excipients or any combination thereof. The audit guideline should be used in
accordance with the current IPEC GDP Guideline for Pharmaceutical Excipients,
published in 2006.