Last week, Rephine won the ‘Industry Partner of the Year’ prize at the Global Generics & Biosimilars Awards held in parallel to CPhI Worldwide in Barcelona, for its work supporting drugmakers by providing GMP and GCP auditing services.
Among its offerings is a library of audit reports carried out to assess suppliers’ products, which the UK-based consultancy firm told us helps pharma companies fulfil regulatory requirements and ensure a secure supply chain.
“A pharmaceutical company is required to have excellent knowledge about the different stages throughout the supply chain and all recent regulatory texts and publications are made with this in mind,” business manager Alasdair Leckie told in-Pharmatechnologist.
“However, the world of chemicals is extremely vast and complex. A pharmaceutical company can spend months looking for and choosing the appropriate ingredient supplier. Rephine has estimated that the process of finding and qualifying a new supplier can take between 15-26 weeks from start to finish.”
According to Leckie, this is partly due to the fact there is no up-to-date platform for searching API suppliers to provide accurate information to the client, and no system to determine the quality of products in the early stages of sourcing.
This can be alleviated through the 5000+ pharmaceutical ingredients audited by Rephine, he said, but the firm is also “looking at designing an online platform for sourcing APIs which could give potential customers an indication of the quality of the products and would help to save a number of weeks work when selecting a new supplier.”
China and India
Rephine conducts roughly 40% of its audits in India and 20% in China, so we asked Leckie about regulatory problems that have surrounded API makers in the region which– according to some industry groups – have caused drugmakers to return to Europe for their ingredients.
“Problems can occur no matter which country an audit is taking place in,” he said.
“[But] what we do find is that manufacturers in these countries are more likely to provide two days for conducting an audit, whereas European manufacturers often only allow one day on-site. This allows our auditors to spend more time looking into systems and [we] are able to conduct a more comprehensive audit and produce a better audit report.”
As for the so-called ‘flight-to-quality,’ he added Rephine has not yet noticed a trend in customers moving away from low-cost markets.
However, he acknowledged “customers do have concerns over data integrity in certain regions and this may lead to a move away from these regions.”