Month: March 2022

FDA Final Guidance on Recalls

The FDA published the final guidance for “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” in March of 2022.

Nothing new here really, as the FDA has just finalized recommendations that companies make adequate preparations to operations in advance of when a recall may be needed (e.g., prepare and execute a recall communications plan). In addition to these preparations, the FDA recommends that companies consider preparing, maintaining, and documenting written procedures (in paper or electronic format) for initiating a recall and performing actions related to initiating a recall. Moreover, the document addresses how companies should develop a recall strategy and train personnel on executing a recall, as well as how companies should use adequate product coding.

Poorly Incentived for Quality

Luis Charles Chavarría recently posted about watches and quality. Reading that, and several of the responses remind how pharmaceutical quality is often just framed in terms of regulatory adherence instead of a broader approach. ISO9001 and other major quality models basically break down to having 8 dimensions of quality.

8 key dimensions of Quality

In a lot of industries, it is very visible to the customer whether quality exists. Shoes, cars, toaster ovens – I can gauge them based on multiple of the criteria above before I buy. I can go on credible review sites, use tools like Consumer Reports, get reliable feedback from others. When a friend recommends a couch, I can trust their opinions.

We have none of that in the regulated areas of pharma and much of medical devices. Patients are prescribed product, and even when there are multiple generics available the only real criteria is price. Chances are the patient barely knows the manufacturer, let alone the manufacturing site. It can be very difficult for a patient, or even doctor, to gauge the quality of the product.

It is for this reason we need more transparency throughout the supply chain, through the development of products. The National Academies of Science, Engineering and Medicine (NASEM) report is a start and needs to be implemented quickly. As a beginning it can really help start to shift the needle and make large parts of this industry more receptive to

Remote Inspections and Computer Systems

The US FDA recently changed the Investigations Operations Manual to allow Investigators direct access to a company’s databases during a BIMO inspection (See Section 5.10.2.1)

As the conduct of clinical and non-clinical trials increasingly moves toward 100% electronic data capture, to include electronic case report forms, medical records, patient-reported outcomes, informed consent systems and other electronic study records, it has become necessary for bioresearch monitoring investigators to have access to these electronic systems and databases in order to successfully perform inspections. Overseeing the firm’s personnel while they access their system is not always practical in BIMO inspections, as this can result in the firm having to dedicate an individual to this task.

FDA Investiations Operations Manual section 5.10.2.1

Obviously, if you haven’t, you should be updating your GCP Inspections SOP, especially since they have a few interesting requirements, such as “While you may complete a form needed by the firm in order to obtain read-only access, such as an account request form, you will not sign such form as per section 5.1.2.3. You may acknowledge via email that you have completed any required training necessary for access.”

I think for many in the GCP world this change is sort of a sleeper change. We have been used to giving access to EMA inspectors for years, who often know more about your TMF than you do by the time they walk in the door.

The real interesting thing is how this spells a shift in attitude at the agency that has been a long-time coming. And how it fits into recent trends in the increase in remote inspections.

Remote inspections are here to stay. Set aside the FDA’s current view that a remote event is not an inspection. And one of the big things that stand out about remote inspections is they do not work well to find data integrity issues, as we’ve seen from the decrease in observations that is not proportionate to the overall size of inspections. I think what we are seeing here is a recognition of that, and the first shift in mindset at the agency.

I’d expect to see the FDA change their approach on the GMP side as they continue to absorb the lessons learned from remote inspections. It is a trend that I would be paying attention to as you continue your digital journey. It is always important to think “how will an inspector view this data”. Usually, we think in terms of printouts. You should also be thinking about read-only access in the near future.

Common Ownership Challenges

Process Ownership Challenges

Governance and ownership challenges often arise in an organization for four reasons:

  1. Business stakeholders who resist assuming ownership of their own processes, data and/or knowledge, or have balkanized/siloed accountability
  2. Turf wars or power struggles between groups of stakeholders
  3. Lack of maturity in one or more areas
  4. Resistance to established governance rules

The Business Struggles with Accountability

Processes often have a number of stakeholders, but no apparent owners. This results in opportunity costs as compulsory process changes (e.g. legislative requirements, systems capacity, or company structural changes) or process improvements are not implemented because the business process owner is unaware of the change, or no clear business process owner has been identified which leads to an increase in risk.

Sometimes processes have a number of stakeholders who all think they are the owners of parts of the process or the whole process. When this overlap happens, each supposed owner often identifies their own strategy for the process and issues their own process change instructions to conform to their understanding of the purpose of the business process. These conflicting instructions lead to frustration and confusion by all parties involved.

Lack of accountability in process and system leads to inefficient processes, organizational disharmony, and wasted energy that can be better spent on process improvements.

Turf Wars

Due to silo thinking there can be subdivided processes, owned by different parts of the organization. For example, count how many types of change control your organization has. This requires silos to be broken down, and this takes time.

Lack of Maturity

Governance is challenging if process maturity is uneven across the organization.

Failure to Adhere to Governance

It can be hard to get the business to apply policy and standard consistently.