From The Editor | April 20, 2023

Create A Quality-System Plan Before Outsourcing


By Louis Garguilo, Chief Editor, Outsourced Pharma


A first piece of advice for those biopharma companies who extensively outsource to CDMOs:

Create and have firmly in place your own quality-system plan.

“It doesn't matter if you're a virtual company and have your experts sitting in different parts of the world,” says Antiksha Joshi, an experienced quality management systems professional who now operates Urmi Quality Management Consulting Pty Ltd..

“Define internally what is needed and what your expectations are for an external partner. Start by asking what are your minimum requirements when it comes to the quality of your products?”

Creating this document could be “as simple as writing your own quality manual filled with expectations." This should be based on the nature of your product, your strategy for development, what part of the world you want to do future trials, and where you want to take the company – whether you want to be acquired or license out in phase two, or go all the way to commercial.

“Simple” might not be the adjective many drug or therapy sponsors would use for this exercise, but after years of working at CDMOs, Joshi holds pat to that assessment. This is an exercise biopharma companies can indeed accomplish.

Moreover, it clearly sets expectations between the two parties.

An initial “writing exercise” – before selecting CDMOs – can effectively save you from delays when creating subsequent documents, such as service and supply contracts, and subsequent work orders.

It also sets a tone with the CDMO you begin to engage with.

Joshi reminds us project "events" can only transpire once projects start, and a high degree of clarity from the onset can mitigate challenges and help to direct appropriate remedies.

There’s also this: Sponsors – more today than ever – tend to bring in new consultants at different stages of development. Personnel changes also seem to occur more often than in the past.

“As I’ve experienced,” says Joshi, “when sponsors’ QC consultants change, they often come in with a different set of expectations. Suddenly, it’s, ‘No, this isn’t the way to do this.’

“It's such a loss of time and waste of resources to both parties. So foremost, any new sponsor should have that quality system document as a guide. It could be 5, 10, or 20 pages. Get your expectations on quality down for the CDMO to review – and also for your consultants.”

That's not to say this document is immutable, but based on that quality plan, outsourcing drug companies can make a predetermination of whether the CDMO is up to the "quality task" over the course of the project life cycle you are contracting for.

Diligence Due Next

The second important factor conveyed from our quality expert, when it comes to sponsors looking for CDMOs, is to allocate time specifically for due diligence of the CDMO’s quality-management system.

From a regulatory standpoint, Joshi says, sponsors are required to perform an audit of the CDMOs they would like to work with to determine whether those CDMOs are able to maintain the required regulatory requirements, are properly licensed, and so on. 

Due diligence is different.

In an audit, Joshi reminds us, there’s only so much time and scope, and what you see is usually targeted and rather limited. Most CDMOs have the basics of the quality system for compliance in place, so they pass that initial audit. 

Because what actually derails so many projects, and impacts the entire sponsor-CDMO relationship, are the subsequent quality-related challenges, while you are in the midst of executing the project.

If a problem arises – a nonconformance – and you then discover the CDMO doesn't have the resources, or proper systems, to address the specifics in a timely manner; or you begin to notice staff turnover at the CDMO and expertise from your project is literally being lost and not replaced, it may be too late to correct course.

“So taking the time to have those conversations at the scoping stage, not just with the BD manager, or the scientists, or even the CEO, but directly with the quality professionals and their managers, is essential.

Joshi gives two buckets of questions as examples of what should be ascertained directly regarding how quality events are managed in process:

  • Who do you assign to projects and investigations? How trained and experienced are they? What do you do if people leave your organization? How often do they leave?
  • What kind of documentation systems do you have in place? If electronic, what are they? If paper, how is that managed? Practically speaking, how do you exchange information with clients?

“In my experience,” explains Joshi, “souring of relationships between clients and sponsors occur on inefficiencies, often associated with particular issues regarding the transfer of information, and in reviewing and analyzing data and documents.”

And, of course, data becomes the coin of regulatory submissions. The value is determined even prior to its minting – before the data starts to get generated – when through your due diligence you validate your service-provider’s quality management systems and operations, and thus the data generated.

Nobody’s Perfect

Joshi ends this part of our conversation by landing firmly in the terra firma of reality.

“All these items we have discussed should be assessed,” she says, “but this does not mean if a CDMO cannot tick every single box, you don't work with them.”

“These efforts can serve to provide you an idea as a sponsor of how much effort you will need to put into a relationship, where gaps are, and how to address them beforehand.”

Perhaps, she says, the CDMO has all the requisite equipment, is able to cater to your timelines and meet your cost expectations, but then you see the people available for assignment to your project are inexperienced. That may be addressable. 

“Quality due diligence gives you a strong foundation on how you can and how you want to build a relationship with them. It allows you to clarify expectations. This is what I mean when I say have your own quality-system plan in place, and perform quality-directed due diligence.”


Chief Editor Louis Garguilo will moderate a discussion with Atiksha Joshi and other professionals Tuesday, April 25 at 2pm EDT. Please join us: