The consultation document - which was published earlier this month - sets out how drug firms should use ICH Q9 to conduct risk assessments of the excipients they use to determine if they are being produced in accordance with 'appropriate' good manufacturing practices (GMP).
Stefan Fuhring from the EC Directorate for Health and Consumers told in-Pharmatechnologist.com the proposals “give guidance as to the risk-assessment to be performed by the finished dosage form manufacturer when sourcing excipients.
Dr Fuhring explained that while there is a legal basis for such assessments under Directive 2011/83/EC “at the moment, there are no EU guidelines to this effect” adding that the draft will be open to public consultation until April 30 and the plan is to publish a final version before 2014.
While the main focus of the proposals is the excipients themselves – with risk assessments taking both the material source and function of the compound in the final drug into account – they also set out how drugmakers should assess their suppliers.
The idea is that manufacturing authorisation holders (MAH) determine an excipient manufacturer’s risk profile, again using ICHQ9 as a guide, and document any gaps identified between required GMP and the firm’s capabilities.
The MAH must then use this information to develop a mitigation strategy.
The requirement that drugmakers check that the excipients they use are made in accordance with GMP (and by implication that manufacturers meet the same standards) was introduced in a directive in 2011 - as is noted above – but until the new draft guidance, suppliers did not know how such assessments would be carried out.
Vice Chair of excipients industry group IPEC Europe Frithjof Holtz, who works in the raw materials team of Merck KGaA's EMD Millipore division, told in-Pharmatechnologist.com that: “We welcome the publication of this long awaited draft, and established a working group analyzing the EU Commission's proposal.”
Holtz explained that: “IPEC Europe has proactively worked on the subject, and developed a process forward that has been shared with various stakeholders,” adding that the organization plans to respond to the EC when it has collected feedback from its members.