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APIs, Quality Agreements and the Partner-or-Supplier Debate.

Neuland-API-PharmaIt’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.  The consensus seems to be that the FDA shifted the responsibility for compliance from the contract manufacturer to the owner of the drug. Holding the owner responsible for their suppliers’ actions, the FDA believes, can potentially lead to fewer compliance issues.

Realistically, it means that those companies hiring CRO/CMOs need to be mindful of their supplier’s ability to deliver world-class compliance and regulatory support.  And companies need to make sure they feel comfortable with the level of participation, information-sharing and oversight they have. In best-case scenarios it means that nothing at all would change, since that level of interaction and sharing hopefully already exists between the pharma company and the contract research or manufacturing organization.

Some drug companies – feeling a bit under the microscope – are pushing for more involvement in their drug’s compliance and regulatory realms. Hence the evolving nature of drug company-CMO interaction, beyond traditional supplier relationships.

Evolution Towards Pharmaceutical Manufacturing Partnerships

One of the outcomes of such regulatory guidance for firms like Neuland has been to adopt more flexibility in structuring CMO relationships with clients. Quite often, we are asked to serve in a traditional supplier role. But more and more frequently we are being asked to form relationships with greater degrees of information sharing and transparency. It’s a reflection of efforts to meet shifting regulatory needs, sure; but it also represents the wider shift towards a quality mindset. Quality demands oversight, and oversight demands data and access.

A couple of months ago, I read an interesting article about the success of the ‘partnership’ model among CMOs and it had one pretty unexpected (for me, anyway) takeaway. The author reported that partnership structures actually tended to have a slightly higher incidence of change orders than traditional supplier relationships – something you wouldn’t expect with the theoretical higher level of integration and communication a ‘partnership’ implies.

For us, there’s been no discernable change. Quality has always been priority number one at Neuland, long before it began the evolution from burden to selling feature. It’s never been a burden or a fad for us… just a prerequisite that must be met.

So no – we haven’t noticed the phenomena of partnerships or more structured relationships leading to a decrease in effective quality management versus traditional supplier arrangements. It’s an interesting finding, though, and it makes you wonder if there were some other common factors that might have been at play – an insufficient data infrastructure for collaboration, for example, or some other issue.

One trend we have noticed of late is an increase in requests to exceed certain spec requirements. Commonly, we’re asked  to go beyond ICH or USP guidelines and meet a higher standard – especially regarding contaminants. Genotoxic impurity thresholds are a great example. Concern is mounting amongst drug companies regarding high-dosage, long-term drugs and the risk of crossing max threshold levels in cases of chronic use (oncology drugs especially come to mind).

The CMO-client relationship will undoubtedly continue to evolve and shift over time, as it always has. From our perspective, at the core of every relationship – long- or short-term – is the supplier’s ability to consistently develop & produce the highest-quality APIs and actives possible. Whatever the formal structure of the relationship between client and CMO, both parties have to be comfortable with the other’s commitment to both quality and open communication.

A successful product demands those two core competencies – everything else is subject to negotiation!


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