Pharmaceutical Microbiology Group

New USP Chapter for the Pharmaceutical Microbiology

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The recently published second USP-NF supplement also contained – for many surprisingly – a new chapter for the microbiological quality control:

This chapter summarises all activities necessary to manage a microbiological lab according to Good Laboratory Practices.

This GLP is different from the GLP addressing e.g. pre-clinical studies. The new USP chapter addresses labs working under GMP conditions.

It specifically mentions that, due to the known variances of microbiological results, fulfilling the requirements is extremely important.

In particular the chapter covers

  • media preparation and quality control,
  • maintenance of microbiological cultures,
  • maintenance of lab equipment,
  • lab layout and operations,
  • training of personnel,
  • documentation,
  • maintenance of lab records as well as
  • interpretation of assay results.

According to the authors, the reasons making an interpretation of microbiological study results difficult are:

  1. Micro organisms are omnipresent in nature and typical impurities from the environment; this is especially the case for micro organisms being in contact with humans and occurring in many microbiological analyses.
  2. Lab personnel can cause the contamination during sample handling or during conducting the test.
  3. Micro organism distribution in the sample and in the environment is frequently not homogeneous.
  4. Microbiological tests often vary considerably. Minor variances from the expected result can thus not be significant.

Discussions during audits and inspections especially with regard to the last item are most likely well known to everybody involved in microbiological quality control.

Altogether the chapter provides a good practice oriented overview over working in microbiological labs according to GMP.

Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA)

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