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 +++ 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:
  

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

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.

Author:
Dr Ulrich Herber
CONCEPT HEIDELBERG
   

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