QUALITY BEFORE TRANSACTION

The opportunity

A client was evaluating an opportunity to supply an essential hospital medicine to a Caribbean healthcare institution. On the surface, the proposition appeared compelling: an available manufacturer, attractive pricing, a defined institutional need and a potential commercial opportunity estimated at US$1 million. Before proceeding, the client asked HENYIDA to independently assess the proposed product and manufacturer. What initially appeared to be a straightforward procurement opportunity became a question of whether there was sufficient evidence to stand behind the quality, safety and reliability of the medicine being supplied.

What we found

HENYIDA's review identified significant gaps in the manufacturer's ability to provide the technical and quality documentation expected to support appropriate product assessment. During our engagement, the manufacturer was unable to clearly distinguish between a Certificate of Analysis (CoA), a product dossier and the Common Technical Document (CTD). When supporting documentation was requested, the manufacturer could not provide the relevant Module 2 quality summaries or Module 3 quality documentation needed to adequately evaluate the product's manufacture, controls and quality. Ultimately, the documentation available to us appeared to consist principally of a Certificate of Analysis. That was not sufficient. A CoA can report results for a particular batch, but it does not replace the broader evidence needed to understand how a medicine is manufactured and controlled, whether appropriate specifications and validated methods are in place, and whether quality can be consistently assured from batch to batch.

Documentation was not the only concern. A site visit provided additional reason for caution. Personnel were observed within fill-finish areas without PPE and gowning practices that HENYIDA considered appropriate for the activities being performed. These observations raised further questions about manufacturing controls and the conditions under which the finished product was being produced. Taken together, the documentary gaps and site observations meant that HENYIDA could not obtain sufficient assurance regarding two fundamental aspects of the proposed medicine: Finished-product quality -including whether the filled ampoules could be consistently relied upon to meet appropriate quality requirements and whether potential defects were adequately controlled; API and batch-release assurance including whether the evidence available was sufficient to establish that the active pharmaceutical ingredient and finished batches consistently met appropriate specifications and release criteria.

The issue was not that HENYIDA had proven the medicine to be defective. The issue was that the evidence and controls available were insufficient for us to responsibly conclude that it was not.

Our recommendation

The commercial case alone could not compensate for the quality uncertainty. Therefore, we recommended that the client not proceed with the proposed manufacturer, despite the potential value of the transaction. We also considered the client's longer-term position. Introducing a medicine into a hospital does not end when the product is delivered. A quality failure could affect patients, the healthcare institution and the reputation of the organization that brought the product to market. Rather than simply advising the client to abandon the opportunity, HENYIDA helped identify an alternative manufacturer capable of supporting a more appropriate quality-assurance pathway.

The outcome

We helped our client recognize that a good price, an available product and a willing manufacturer do not, by themselves, make a medicine a responsible procurement. The client avoided proceeding with a supply source that HENYIDA could not adequately qualify, protecting both the integrity of the procurement decision and the client's reputation while preserving the underlying commercial opportunity through an alternative sourcing strategy. For HENYIDA, the decision reflected a simple principle:

If we cannot stand behind the quality, we will not recommend the transaction.

Product, client, manufacturer, healthcare institution and market details have been withheld to protect commercial confidentiality.

FROM STANDARD TO ROADMAP

The challenge

A regional clinical diagnostics laboratory was working toward ISO 15189 accreditation and needed a structured approach for moving from its existing operations to accreditation readiness. The challenge extended beyond understanding the standard. Achieving accreditation required coordinating quality systems, laboratory operations, documentation, workforce readiness and organizational responsibilities within a manageable implementation plan.

Our role

HENYIDA provided project management and implementation support, helping translate the accreditation objective into a structured roadmap. The work included assessing the pathway to readiness, organizing requirements into actionable workstreams, identifying dependencies and priorities, defining responsibilities and sequencing activities to support progressive implementation.

The approach

Rather than treating accreditation as a single compliance exercise, the roadmap established a practical framework for managing the work across the laboratory and tracking progress toward readiness. This gave laboratory leadership a clearer view of what needed to be done, at what cost, in what order, by whom, and how the individual activities contributed to the overall accreditation objective.

The result

A complex international standard translated into a structured, manageable implementation roadmap for laboratory leadership and its team.

Client and laboratory details withheld for confidentiality.