Webinar: QC testing of culture media
An on-demand webinar covering the use of control strains for QC testing of culture media.
Soliris Recall
A recall of Alexion's orphan drug soliris due to particulate contamination identified in vials. Interesting that the particles were identified following routine testing of retained samples. Did the CMO have a validated method for particulate testing? If not, then where was the QP oversight?
QP review of BMRs
An interesting overview by the ECA on the expectation of the QP on reviewing BMRs prior to certification
APIC guideline for contracted QC
This guideline covers the management & qualification of contract QC labs
Monoject Recall - FDA
A recall of flush syringes used to maintain paucity of patient infusion lines. Major failures in segregation and sterilisation control are obvious.
FMD finally transposed
I'm sure you have heard about this already but worth looking at an alternative view regarding changes to professions who can now legally prescribe and supply your products.
Webinar: RA for global registrations
Webinar: GMP for EM systems
FDA's lack of power over compounders
An interesting article highlighting the limits of the FDA's authority over compounders in the USA. Looks like the FDA is stuck between a rock and a hard place.....
BFS overview
A short youtube clip showing the process of blow-fill-seal technology. Youtube is an excellent source for getting overviews of processes not familiar to you and for preparing for your visits.
How the FDA assesses defect reports
A great insight into how the FDA assesses defect reports. I'm sure the DMRC will have a similar process.
The role of Microbial Testing in Biotech
A comprehensive article exploring the microbial testing requirements for biotech products.
Happy Reading!
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