The company – who also told in-PharmaTechnologist.com about its plans to expand in the developing markets earlier this week – explaining that it aims to be “proactive rather than reactive” in ensuring GMP is carried out, as well as in controlling all stages of supply.
Guy Matthews, EU technical manager, risk mitigation, said: “A lot of what happens in pharmaceutical risk mitigation is driven by events.
“For instance the recent demand for animal-free product was driven by the BSE crisis. That’s when we as an industry started really looking at manufacturing.
“In the 2008 Heparin incident, companies didn’t understand where their raw materials were coming from, and didn’t have sources with regulatory monitoring.”
Conducting audits
As part of the plans, the company has put in place its own audit offering.
And though those involved admit the program has not been without its issues, the company is positive it can provide a cost effective service which can appease the regulatory bodies.
Ed Roullard, VP marketing for SAFC on supply chain and quality management said: “After recent issues in supply chain management, the FDA has told customers they need to regulate and control their own supply chains.
“And what we have now is pharma companies asking every question it can ask which costs everyone time and money.”
SAFC now say they can answer 90 per cent of all client questions through their daily audits, which cost around $5,000 per time.
“We look at not only the testing, but at the possible risks, what could happen. It’s all to do with pre-empting,” said Roullard.
As part of the pre-emptive tactic, the firm suggests removing components with highest risks such as animal derived products, and other biological and agricultural factors.
EU technical manager Matthews also spoke of implementing “layer of protection” throughout the production process, rather than simply testing the end product.
Trust issues
However, SAFC say that the industry still has a way to go if it is to work together on supply chain and quality management.
Roullard added: “The real shame is that we have the same audit from the same facility more than once sometime, because the different departments don’t trust each other.
“We started to say lets work together with the customers on the audit results, and welcome them to share the results with everyone. It’s a risk because if something goes wrong it’s shared with everyone.
“For the bigger companies this might not always work. Say if someone like Merck did an audit, Pfizer might not then take on the results from the other company.
“The pharma industry should not be competing on supply chain and quality management, they should be working together.”