Analysis of Our Internet Survey of 28 August 2003

GMP News No. 351

GMP News
22 September 2003

Analysisof Our Internet Survey of 28 August 2003

During the past weeks, there have been many discussions about the revisionof Annex 1 to the EC GMP Guide and the new Draft for FDA's"Aseptic Guide." The new documents have caused great uncertaintywithin the industry about how to proceed from now on.

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

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

We have summarised the survey results in the following diagrams. Theyshow the percentages of the number of ticks for each of the possibleanswers.

  • How do you carry out particle measurement in thedifferent cleanroom areas?

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

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

  • For particle measurement, a sample volume of not less than 1m3 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 measuredvalues

The meaning of some technical terms was hotly debated during thesurvey, e.g. that of "continuous" and "discontinuous"in connection with measurements to be conducted in the different cleanroomareas. 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 questionthat was frequently asked was why there are differences between thestandards.

We would like to take this opportunity to thank all those who haveparticipated in the survey. The large number of filled-in questionnairesand the diverging results have shown that the requirements and terms in thenew documents need to be clarified.

Harald Martin


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