Update to EU GMP Part I Chapter 6: Quality Control הדפסה
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שלישי, 29 אפריל 2014 22:20

 

The new update to chapter 6 of the EU GMP will come into operation in October 2014. This chapter deals with Good Quality Control Laboratory Practice (GQCLP; not GLP), laboratory documentation, sampling for the laboratory during production, laboratory testing, the on-going stability programme, and the entire new section about technical transfer of testing methods.

 

The major changes in this update are about:

 

  • Cross-contamination issues;
  • Investigation, according to a procedure, of Out of Specification (OOS) and Out Of Trend (OOT) results;
  • Trending of important data;
  • ALL testing methods should be validated or, at least, verified;
  • Reference standards;
  • Microbiological culture media

In the file attached, the sentences which have been omitted from this revision are in red, and the new ones are in green.

 

עדכון אחרון ב-שלישי, 29 אפריל 2014 22:50