UK Regulator Tests Using Consultancy Firms To Monitor GMP, GDP Compliance
Novel Approach Aims To Do Away With Frequent On-Site MHRA Inspections
The MHRA is testing the feasibility of appointing eligible external consultants to be its eyes and ears when it comes to checking up on drug companies that have failed to meet good manufacturing and distribution practice requirements.
You may also be interested in...
Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements.
The UK medicines regulator is planning to levy additional fees to recover the costs associated with the extra time spent by inspectors in following up or reviewing non-compliance cases referred for further action.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.