Bioburden And The New EU GMP Annex 1: Risk Assessment, Reduction, And Testing

Contamination control strategies (CCS) were a hot topic in discussions leading up to the revision of EU GMP Annex 1, and some of the guideline’s principles can be applied where filtration is used for bioburden reduction of, for example, low-bioburden biological intermediates.

Experts on regulation, filtration, sampling and QC discuss risk assessment and filtration-based strategies to reduce bioburden.