In an interview at CPhI Patricia Rafidson, chair of IPEC Europe, explained the measures that the body will be taking to address the issues facing its members.
The development of a certification standard is high on IPEC’s agenda, with the organisation partnering with the European Fine Chemicals Group (EFCG) to implement this.
This will create a ‘certifiable standard’, based on earlier work by the industry group and others in setting good manufacturing practice (GMP) and good distribution practice (GDP) standards, which IPEC hopes will demonstrate the industry’s commitment to delivering high quality products.
In essence, certification would create a system whereby excipient suppliers could become accredited by third-party organisations. Ideally, the accreditation groups would in turn be endorsed by regulatory authorities.
Although the contaminated glycerin and heparin cases represent a tiny proportion of all ingredients used in pharma, these cases have put the industry under the spotlight, and IPEC is keen to demonstrate the industry is proactive in its approach to product quality.
More information on how you qualify an excipient and better control of the supply chain were picked out as two measures that need to be pursued.
When in place the certification scheme will be run by EFCG in conjunction with IPEC Europe in their home continent, with IPEC Americas responsible for its region of the world.
Looking further ahead, Rafidson explained IPEC’s desire to promote excipient innovation by increasing the level of intellectual property protection for those who develop novel products.
This will involve the creation of excipient master files (EMFs) for novel and biological/biotechnological excipients. To start this process IPEC’s regulatory affairs committee has opened a dialogue with the European Commission to communicate the benefits of master files.
Rafidson acknowledged that the necessary complexity of the system was slowing progress. However, by being proactive and creating a proposal she believes IPEC has the best chance of seeing a system implemented that is effective for all parties.
Global harmonisation of standards
Harmonisation is high up on IPEC’s agenda, with the organisation working towards the development of common safety systems for the regions covered by TriPEC, which consists of Japan (JPEC) as well as the European and Americas branches.
The role IPEC China will play is not yet clear, although its chairman, Nevin Cheng, has said he believes the organisation must become a “harmonisation bridge between China and other countries.”
This suggests that IPEC China will play a role in the harmonisation progress but Cheng has also acknowledged that because: “IPEC China is a very new organisation, it needs support from local industry and government [as well as] global sister associations.”