Quality Goes Way Beyond a Few Regulations

The quality profession in the pharmaceutical industry is wider than the overseeing regulations from health authorities. The GXPs are truly a starting point, not an ending point which is why we often use that little “c” for “current.”

The GXPs (and the regulations behind them) serve an important purpose. But they are the start of excellence and not the end.

The GXPs are an outline. When we start with these requirements and then fill in the details we build a robust and beautiful engine for quality.

The 5Ps of GXPs: People, Procedure, Product, Premise, and Principles.

This is often why we talk about compliance being the start of quality, and not the end.

Critical ATMP Deficiencies

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.

Lilly in the news

“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.

References and Related Documents in Procedural Documents

It is pretty standard advice that relevant references to other documents should be listed in a separate section of the procedure. The reasoning is that when some standard operating procedures are intimately linked to others – the information contained in more than one document is necessary to complete a task – it is useful to include a cross-reference section in each document. Many also say that this section reinforces the SOP’s authority.

Another fairly common piece of advice is to have this, or another, section in the procedure identify the documents used in the development of the procedure, such as regulatory documents or technical/validation reports.

My take is that neither belongs in a process/procedure (SOP/WI). We should be looking to streamline requirements documents, and these sections are just cruft.

If you have electronic document control systems then cross-references should be handled trough hyperlink. Users are quite comfortable with hyperlinks and will easily navigate between documents.

Listing of regulations and other requirements belongs in a separate design document (ideally part of the document control system), and again add little value to the execution of the document.

There are a lot of so-called “best practices” about documents that stem from the days where everything is paper, and it is okay to move beyond them.

Embarrassing Photos

This photo is on the embarrassing side.

Messy Moderna binders from https://hbr.org/podcast/2020/11/remote-feedback

If I stumbled across this on a gemba walk there would be coaching on proper storage techniques of documents. My only hope is some corporate communications person made it this way on purpose and the poor person in the photo was muttering under their breath the entire time.

There is an opportunity here on connecting with communications team on best ways to showcase GxP activities. I recommend writing a good policy on the subject and ensuring it is appropriately bought into.