GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?

GMP News No. 563

GMP News
30 May 2005


GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10?

A few days ago, the International Conference on Harmonisation published a report on the ICH Meeting held in Brussels on 11 and 12 May. In this report, ICH informed among others about further activities in the field of the "Quality" guidelines. After recently publishing the two guidelines ICH Q8 "Pharmaceutical Development" and ICH Q9 "Quality Risk Management" as step-2 documents, an informal Expert Working Group of ICH now deals with the subject of "Quality System for Continuous Improvement". For some time now, there have been discussions about the possibility to publish an ICH Q10 guidance on this topic. The Steering Committee has asked for a detailed business plan before the formal work on this guidance can begin.

In the past, the US-American FDA, which is a member of ICH next to EMEA and the Japanese medicines authority, stated that the topic of "Pharmaceutical Quality Systems" could well become the title of a worldwide harmonised guideline. How high this topic is ranking in FDA's priority list is shown by the publication of the Draft "Guidance for Industry: Quality System Approach to Pharmaceutical Current Good Manufacturing Practice Regulations" in September 2004.

Dr Lester Crawford, FDA's Acting Commissioner and thus the highest representative of this organisation, gave a topical lecture which also covered the subject of "Improving Manufacture Practices" before the Food and Drug Law Institute on 7 April 2005. In this lecture, he pointed out that:

"Good manufacturing practices are not only vital to business success; they are also essential to FDA and they are essential to the public health. 

The FDA's overhaul of the pharmaceutical cGMPs encourages manufacturers to modernize their methods, equipment and facilities that will help eliminate both production inefficiencies and undue risks for consumers. Our initiative also implements tougher inspections rules to make them more targeted and effective.

With reference to the closure of a manufacturing plant for vaccines in England due to GMP deviations, he stressed the importance of FDA's co-operation with other authorities (in this case the MHRA).

Therefore, the FDA currently supports a further harmonisation of GMP standards. Harmonisation via ICH is one step to reach this aim. In addition, the Agency is considering another possible step: becoming a member of PIC/S ( 

Apart from this, the FDA is obviously having a look at completely new models. FDA is examining the possibility to open offices outside the USA! Until very recently, articles of that content published in pharmaceutical journals were held to be false reports. Now the English journal Scrip (one of the most reliable media in the pharmaceutical environment) quotes Dr Lester Crawford as follows:

"We are asking for more funds in this budget for this kind of activity and we also are shifting personnel in order to be able to do this. The only glitch in the three years I've been back [at the FDA] that needs desperate fixing is that sometimes we have to go into areas to do these inspections ... where the State Department cannot guarantee our safety."

The article continues:

A spokesperson for the FDA told Scrip that the agency's "international responsibilities and travel requirements have increased not only in frequency but also in scope in terms of the places we go to conduct inspections and to work with our international counterparts on global public health issues." However, Dr Crawford was not available to amplify his remarks "due to his full schedule", the spokesperson said.

Global GMP harmonisation as well as the latest ICH developments will be discussed at a unique conference on 20-21 June 2005 in Heidelberg. 
Participants from 19 (!) countries have already registered. Only few places are left at the

European GMP Conference

Conference co-operation with the University of Heidelberg, the German Federal Association of Pharmacists in the Civil Service (BApÖD) and the European Compliance Academy (ECA). Speakers from FDA, EMEA and the ICH Expert Working Groups have confirmed to give lectures at this outstanding event.


Oliver Schmidt

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