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.
Today Janet Woodcock issued a statement “FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines” which links to the April 2021 Form 483 of the Baltimore facility.
- Failures to investigate deviations
- Failures for material management
- Failures for gowning
- Failures of the cleaning program
- Failures in facility design
- All around failure for contamination control
- Failure to have a comprehensive training program
I have requested hearings from my congressional representatives. The path where Emergent received so much money from the federal government to lead to this place is frightening.
The latest version (version 14) of the “How to do” Document – Interpretation of ICH Q7 Guide and “Review form” for APIs was published a few months back. It is intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on interpretation.
In this version, the responsible Task Force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), mainly made additions and updates in chapters 11 – Laboratory Controls, 15 – Complaints and Recalls, and in section 16 – Contract Manufacturers (incl. Laboratories).
The addition in section 11.11 for “Approval/rejection of materials” is pretty striaghtforward – have an SOP.
The changes in section 15 for recalls is pretty cosmetic.
I would re-read section 16 on contract manufacturers. Not much substantial here, but the rewrite makes it a good time to ensure compliance.