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

GMP News No. 563

GMP News
30 May 2005


GMPTrends: FDA Offices Outside USA? Quo Vadis ICH Q10?

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

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

Dr Lester Crawford, FDA's Acting Commissioner and thus the highestrepresentative of this organisation, gave a topical lecture which alsocovered the subjectof "Improving Manufacture Practices" before the Food and DrugLaw 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 inEngland due to GMP deviations, he stressed the importance of FDA'sco-operation with other authorities (in this case the MHRA).

Therefore, the FDA currently supports a further harmonisation of GMPstandards. Harmonisation via ICH is one step to reach this aim. Inaddition, the Agency is considering another possible step: becoming amember of PIC/S ( 

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

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

The article continues:

A spokesperson for the FDA told Scrip that the agency's"international responsibilities and travel requirements haveincreased not only in frequency but also in scope in terms of the placeswe go to conduct inspections and to work with our internationalcounterparts on global public health issues." However, Dr Crawfordwas not available to amplify his remarks "due to his fullschedule", the spokesperson said.

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

European GMP Conference

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


Oliver Schmidt


Go back

GMP Conferences by Topics