+++ New +++ The
topical GMP survey: What is standard practice? +++
From now on, we intend to research the standard practice in the
pharmaceutical industry in relation to current GMP topics. In short, we
would like to know: What do you do in your company? We will ask you
especially in case we receive many questions concerning the interpretation
of new regulations.
At the moment, we often hear the question:
Is it possible to
fulfil the new requirements of the revised Annex 1 to the EC Guide on
the 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 number
of questions regarding particle measurement. In order to get an idea of the state
of affairs in the pharmaceutical companies, we would ask you to fill in the below form and to
send us the data by clicking on the corresponding button.
After analysing the
results, we will, of course, publish the compiled information in the form
of a GMP News.
The questions refer exclusively to Note (a) to the table titled "The airborne particulate classification for these grades is
given in the following table." (at the top of page 3 of Annex 1). You
will find the unabridged document at:
http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/revan1vol4.pdf.
The survey is anonymous. Please fill it in only in case you work in a
pharmaceutical company that has cleanrooms.
Now, these are our questions:
How do you carry out particle measurement in the different
cleanroom areas?
Grade
Continuous
Discontinuous
A
B
C
D
In case you already practice continuous measurement, do you
additionally conduct routine testing?
YES
NO
Note (a): "… For routine testing the total sample volume should
not be less than 1 m3 for grade A and B areas and preferably
also in grade C areas…."
How do you carry out routine testing in the different
cleanroom areas?
Grade
Method
A
B
C
D
Measurement according to monitoring
plan
Measurement within the framework of
requalification
No routine testing
For particle measurement, a sample volume of not less than 1 m3
is required.
How do you fulfil this requirement?
1 m3 per sampling point
1 m3 as the sum of all sampling points
measurement over a
limited time and projection of the measured values
In case you would like to give us your comments on this topic, please
type them in the following field.
Comments:
(For participating in the survey, you will get a voucher
worth 50 EUR for the event "Qualification/Validation
in Sterile Manufacturing" on request. If you would
like to receive this voucher, please indicate your name and address in the
comment field.)
Thank you for taking the time to answer our questions! As soon as we have
analysed the survey feedback, we will inform you about the results in the
form of a news.
A panel discussion on Annex 1 has now been included into the programme
of the pharmaceutical conference "Pharmaceutical
Facilities" to be held in Vienna, Austria, in October. Among the guests of the discussion are Dr J.
Neuhaus, GMP Inspector from the Regional Administration in Cologne and one
of the leading experts in the field of sterile manufacturing in Europe, as
well as Mr T. v. Kahlden, long-standing member in VDI and ISO committees
on cleanroom technology.
