GMP News - Aseptic / Microbiology

After 2019 and 2021, the FDA will again update its findings and recommendations regarding bacterial contamination of platelet preparations for transfusion purposes.

FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

With the publication of the final version of the revised Annex 1 in August, the ECA Foundation's CCS Task Force got together again to update the CCS Guide based on the final Annex 1 version. The new CCS Guide version 2.0 now comprises the revision of quoted passages, the modification and insertion of individual sections and tables as well as an improved clarity and the update of the attachments.

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

Particulate contamination and inadequate aseptic working techniques while performing interventions during production once again led to a serious Warning Letter from the FDA. What did the FDA criticise and what did it demand from the American company Cangene BioPharma, LLC dba Emergent BioSolutions?

After more than five years and two public drafts for comment, the European Commission this week published the final version of the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products". Learn more about deadlines and changes compared to the 2nd draft version for comment from 2020.