This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) finally announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.
This final version is of a draft document originally introduced in 2016 and re-issued as a draft in 2018. It’s been a long road to get final version. Final version here.
ERC The Netherlands B.V. received thirteen deficiencies from a recent inspection, one of which was classified as a critical deficiency.
These were mainly related to five main components:
- Quality and safety of starting materials. Inspection of chemicals and consumables is insufficient.
- The quality and safety of the final product is not guaranteed. The product is not sufficiently defined and characterized.
- The effectiveness of a gama irradiation step, and therefore the safety of the product, is not guaranteed.
- The change for the transition from Contractor 1 to Contractor 2 for gamma irradiation of cells has not been carried out as referred to in the GMP for ATMPs.
- Prevention of (cross) contamination is not sufficiently guaranteed.
- The environmental monitoring program and personnel monitoring are inadequate.
Reviewing this together with Emergent’s 483 (and resulting actions) starts to define a set of concerns in the ATMP world.
“rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial.”“Lilly hit by staff accusations, FDA scrutiny at COVID drug factories“
Yesterday Reuters published a piece based on a purported recent internal complaint at Lilly on a Quality leader purportedly falsifying data.
This comes on top of a March report that “Insider alleges Eli Lilly blocked her efforts to sound alarms about U.S. drug factory.”
Lilly has had several decades of “promising to address GMP issues.” Are these signs of not addressing cultural issues? Of the balkanization of fixes? Of the infamous pendulum swing? I have no insight, but as an individual who was involved in the work of consent decree remediation at another company, I certainly have lots of questions about what is up at Lilly.
Shakeups at Emergent
There is a lot to understand in this story. As congressional hearings unfold, and the shareholder lawsuit works the way through the courts, I hope we learn more about the how’s and the why’s.
I will admit to having a bit of bias against herbal supplement manufacturers. As an industry they are underegulated, and yet still seem to rack up the cGMP observations.
This Warning Letter does nothing to disprove that bias.