Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products?

GMP News No. 339

GMP News
28 August 2003

 +++ New +++ Thetopical GMP survey: What is standard practice? +++ 

From now on, we intend to research the standard practice in thepharmaceutical industry in relation to current GMP topics. In short, wewould like to know: What do you do in your company? We will ask youespecially in case we receive many questions concerning the interpretationof new regulations.

At the moment, we often hear the question: 

Is it possible tofulfil the new requirements of the revised Annex 1 to the EC Guide onthe Manufacture of Sterile Medicinal Products?

The new Annex 1 to the EC GMP Guide comes into force on 1 September 2003.Since its publication on 3 June this year, we have received a great numberof questions regarding particle measurement. In order to get an idea of the stateof affairs in the pharmaceutical companies, we would ask you to fill in the below form and tosend us the data by clicking on the corresponding button.

After analysing theresults, we will, of course, publish the compiled information in the formof a GMP News.

The questions refer exclusively to Note (a) to the table titled "The airborne particulate classification for these grades isgiven in the following table." (at the top of page 3 of Annex 1). Youwill find the unabridged document at:

The survey is anonymous. Please fill it in only in case you work in apharmaceutical company that has cleanrooms.

Now, these are our questions:

Note (a): "… A continuous measurement system should be used formonitoring the concentration of particles in the grade A zone, and isrecommended for the surrounding grade B areas…."

How do you carry out particle measurement in the differentcleanroom areas?


In case you already practice continuous measurement, do youadditionally conduct routine testing?


Note (a): "… For routine testing the total sample volume shouldnot be less than 1 m3 for grade A and B areas and preferablyalso in grade C areas…."

How do you carry out routine testing in the differentcleanroom areas?



Method  ABCD
Measurement according to monitoringplan    
Measurement within the framework ofrequalification    
No routine testing    

For particle measurement, a sample volume of not less than 1 m3is required.
How do you fulfil this requirement?

1 m3 per sampling point 
1 m3 as the sum of all sampling points 
measurement over alimited time and projection of the measured values 

In case you would like to give us your comments on this topic, pleasetype them in the following field. 




Thank you for taking the time to answer our questions! As soon as we haveanalysed the survey feedback, we will inform you about the results in theform of a news.

Dr Ulrich Herber


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