GMP News - Inspections/Audits


FDA, EMA and TGA Inspection Programme with impressing Result

The international pilot programme for conducting GMP inspections at API manufacturers is an impressive success. The pilot programme's provisional results were summarised in the interim report on 23 September. Find out more.



FDA provides Tips for Inspections

On its Medicinal Devices website the FDA provides -very succinct - tips regarding the course of an FDA inspection. This document can be recommended for pharmaceutical companies as well. Read more here.



FDA Inspection Reports: What is what?

We are asked about the different inspection reports of the US-American health authority FDA (US Food and Drug Administration) again and again. In this newsletter, we would like to present the three most important documents to you. Read more.



EMA and US FDA seek potential Candidates for joint GMP Inspection Programme

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Read more about the programme.



Shared Audit at Pfizer's Manufacturing Site in the US

On 15-16 March 2010, a regular re-audit was performed at Pfizer Global Manufacturing in Kalamazoo, USA. Click here to read more.



Database "QPSHARE" for Planning Joint Audits Already Used Intensively

Recently, the European Qualified Person Association made the database "QPSHARE" accessible to its members, which enables QPs to increase the efficienvcy of the supplier qualification of their companies. The database is already used intensively. Read more here.



Shared Audits: How Can You Find Partners in Order to Share Audit Costs?

'Shared audits' are on everyone's lips. The term describes the fact that several firms hold a joint audit of the same supplier. Such a procedure can reduce the costs considerably. Read here how this can be done and what has to be taken into account.


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