When introducing Valeant’s Senior Director of GMP and QA Compliance Robert Sparadoski this morning, the Chairman of the 13th Annual Biological Production Forum 2014 in Dublin, Ireland stated he did not know of any pharma firm which utilized so many contract manufacturing organisations (CMO).
Valeant currently works with 826 CMOs, though Sparadoski admitted he used the term loosely to mean service providers, with 128 working with Valeant and its subsidiaries in the development stage, 213 in quality and 485 in production.
However, with Valeant pursuing an aggressive acquisition and integration strategy – the firm is currently embroiled in a possible takeover of Allergan, which would eclipse last year’s $8.7bn acquisition of Bausch + Lomb – the number of vendors is likely to keep increasing and thus it is necessary to deal with them “in a way that is manageable.”
“It’s really important for us to understand [our CMOs’] compliance history; will they work for Valeant and were there any process issues?” he told the room. “How we do this is by using a cloud environment.
“All of our CMOs have different quality systems and records,” he added, and the cloud operated by Microsoft SharePoint ensures Valeant knows how each CMO is operating, and vice versa, with signals sent between the firms immediately when actions are required, as well as for showing metrics and the reporting of data.
With some clouds comprised of over a terabyte of data, this is a task that cannot be done efficiently via email, Sparadoski continued. Furthermore, the cloud streamlines communications and can reduces costs, for example by doing quality reviews via the cloud rather than by visiting the site.
Outsourcing-Pharma.com asked Sparadoski how Valeant ensures all the data is kept safe on the system. He said a number of controls are in place to maintain the integrity and privacy of our CMOs, including in-house negative and challenge testing of the systems on top of password security, numerous password levels and e-signatures where needed.
“Sainmhinithe” for control and compliance
Being in Ireland, Sparadoski used the Gaelic word “sainmhinithe,” meaning operational definitions, to explain Valeant’s scalable monitoring process in its collaboration with vendors.
“Supplier management is a key integral entity within the global sourcing process and virtual model,” he said, with Valeant forming “solid quality agreements” with all its suppliers involving clearly defined roles and responsibilities and the tightening up of contracts, including using two-way to multi-way agreements and using a template model where necessary.
Furthermore, issues are reported using a five point scale – one relating to a minor issue, five regarding materials or services critical to safety – he said, allowing Valeant to be in control and respond appropriately to ensure compliance.
Asked whether Valeant had blacklisted any CMOs, he told a gossip-hungry room the company had, though of course he would not name names. However, many of these were smaller CMOs who were perhaps not incompliant but just averse to working using Valeant’s model.