As regulatory inspections of sterile and aseptic manufacturing are becoming more severe resulting in an increase in warning letters, Hoffmann-La Roche has put in place a ‘Sterile Oversight Strategy’ in order to govern its external manufacturers.
Speaking in London, UK at the Global Pharmaceutical Contract Manufacturing (GPCM) Event, Jean-Jacques Kielwasser – responsible for external manufacturing at Roche – said the firm’s decision of implementing its ‘Sterile Oversight Strategy’ was critical in creating a “leaner network but with stronger partnerships”, and involved four key areas:
- Increasing all sites, Roche or otherwise, to safety level 3
- Having a ‘person in the plant’ (PIP) at all external sites
- Creating a ‘Task Force Guidance’ on known risks, including: plant shutdown, equipment reliability, inadequate management and environmental control
- Accessing all the CMO’s KPIs without waiting for monthly reports though its KPI measuring Performance Reliability Tool (PRT)
With regards to the PRT, Kielwasser said this wasn’t so much an audit but a regular three-monthly observation of the manufacturers compounding, filtration, aseptic filling and labeling processes and, with such high standards, could result in Roche ordering batches to be destroyed which the CMO considers fine.
Stepping on CMO's Feet?
Such governance led to questions by a number of CMOs in attendance, including Hospira – who has been at the forefront of a number of recalls and warning letters in recent years – who asked how Roche’s higher expectation than that of its manufacturer could work costwise.
Kielwasser answered cost of destroyed batches would be split between Roche and the CMO depending on the contract and the actual problem itself.
Furthermore, it was asked whether this was an intrusion into the business of CMOs and whether they were cooperating with Roche because of the buying power of the Big Pharma company.
Kielwasser said that though clients wanted to keep Roche as a client, they could also see the benefits of such vigilance, bringing in training and support to the CMO as a whole.
“CMOs have commented on how Roche is so committed to this quality standard, far more than other Big Pharma,” Kielwasser told Outsourcing-Pharma.com.
Reduction in Partners
This, he continued, is also just a temporary measure and is part of a strategy to reduce the number of CMOs Roche is partnered with.
When asked if this was evidence of a move back to inhouse manufacturing, Kielwasser told this publication the reduction was due to the cost of such governance by Roche, and therefore it was better to have a smaller, more secure network.