GMP News - Inspections/Audits


Inspection of API manufacturers: First Results of the WHO Pre-Qualification Programme

Within the framework of its pre-qualification programme of APIs, the WHO has published detailed results about the inspections performed at API manufacturing sites. Information about the GMP deviations found as well as further interesting facts can be found here.



DMA Document on Expectations for Audits of API Manufacturers

The Danish Medicines Agency (DMA) has published a document entitled: The Danish Medicines Agency's expectations for audits of API manufacturers. The DMA defined a number of expectations which need to be fulfilled if the QP delegates the task to a third party.  Read more here.



FDA Inspections: Current Initiatives

The globalization of the pharmaceutical supply chain and the quality issues that have arisen because of that globalization, the FDA initiative "Pharmaceutical Quality for the 21st Century" and resource constraints that all Health Authorities are feeling are all changing the way FDA is viewing their mission to protect the American consumer.  Click here to get an overview about the current initiatives.



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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