Tabriz Consulting Ltd.
Pharmaceutical QA and GMP/GDP Consultants

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.  

Click Here for Details

IMB issued New GDP Guideline for Wholesalers.

(CLICK HERE for details)


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

(CLICK HERE for details)

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. 

                                                                              (CLICK HERE for details)