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GMP News
22 September 2003
 

Analysis of Our Internet Survey of 28 August 2003
 
During the past weeks, there have been many discussions about the revision of Annex 1 to the EC GMP Guide and the new Draft for FDA's "Aseptic Guide." The new documents have caused great uncertainty within the industry about how to proceed from now on.

After receiving many questions, we started a survey in order to inform ourselves about the current industry practice concerning the implementation of the requirements laid down in the revised Annex 1 to the EC GMP Guide.

The survey results have revealed that the approaches differ greatly between the companies, e.g. regarding particle monitoring.

We have summarised the survey results in the following diagrams. They show the percentages of the number of ticks for each of the possible answers.

  1. How do you carry out particle measurement in the different cleanroom areas?

  1. In case you already practice continuous measurement, do you additionally conduct routine testing?

  1. How do you carry out routine testing in the different cleanroom areas?
     
    The possible answers were:
    - Measurement according to monitoring plan
    - Measurement within the framework of requalification
    - No routine testing

  1. For particle measurement, a sample volume of not less than 1 m3 is required. How do you fulfil this requirement?
     
    The possible answers were:
    - 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

The meaning of some technical terms was hotly debated during the survey, e.g. that of "continuous" and "discontinuous" in connection with measurements to be conducted in the different cleanroom areas. What was also unclear was the exact meaning of "requalification" and "routine testing."

The comparison between Annex 1 and the new Draft for FDA's "Aseptic Guide" provided further topics to discuss. One question that was frequently asked was why there are differences between the standards.

We would like to take this opportunity to thank all those who have participated in the survey. The large number of filled-in questionnaires and the diverging results have shown that the requirements and terms in the new documents need to be clarified. Therefore we recommend you the following events:

Author:
Harald Martin
CONCEPT HEIDELBERG