14/15 April 2021
GMP News No. 339
+++ New +++ Thetopical GMP survey: What is standard practice? +++
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?
For particle measurement, a sample volume of not less than 1 m3is required.
In case you would like to give us your comments on this topic, pleasetype them in the following field.