New IPEC GDP Audit Guideline Document
EU GDP Inititives
EMA & FDA TO share Audits!
European Commission has issued the new draft of 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.
The initiative to share work on inspections
of manufacturing sites in each other’s territories starting in January 2012,
will enable the two authorities to rely on each other's inspection outcomes
rather than carrying out separate inspections in duplicate.
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.