GMP News - Inspections/Audits

Wholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. If the outcome of an inspection is that the wholesale Distributor does not comply with Good Distribution Practice, a statement of non-compliance may be entered into EudraGMDP. For your information please see the comprehensive overview of the GDP non-compliance reports entered in 2021 and the respective reasons for issuing them.

In September 2021, the International Pharmaceutical Excipients Council Federation (IPEC Federation) announced the availability of the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients (Version 3, 2021). After the guide was initially only accessible exclusively to IPEC members for three months, the document was now made available to the general public.

The ICMRA has published a report on remote inspections with valuable advice for the pharmaceutical industry, also for its own preparation and implementation.

As international travel restrictions remain in place, the TGA's GMP remote inspection programme will continue. This means remote inspections remain the only available option for certification applications during the pandemic.

Only recently, we reported that in fiscal years 2019 and 2020, deficiencies in the stability programme in the area of "drugs" were mentioned in numerous FDA 483 forms. The FDA has now published the data for the fiscal year 2021. About a fifth of the 483s revolve around the issue of stability.

The EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents.