chromatography packing life verification required equipment
According to the quality control regulations for raw materials and excipients used in biological products production, part 3 of the 2015 edition of Chinese pharmacopoeia, chromatography packing is classified as grade 3 raw materials with medium risk, and corresponding quality control should be carried out. The third part of the 2015 edition of Chinese pharmacopoeia, general introduction of recombinant monoclonal antibody products for human use, requires verification of the acceptability of repeated use of purification materials. In addition, ICH, FDA and other relevant agencies also clearly pointed out the need to verify the service life of the chromatography filler.
Download：chromatography packing life verification required equipment